Demo logical data model
1.0.0 - STU1
Demo logical data model, published by My Organization. This is not an authorized publication; it is the continuous build for version 1.0.0). This version is based on the current content of https://github.com/wgroup6/11615 and changes regularly. See the Directory of published versions
| Active as of 2023-10-31 |
Definitions for the InvestigationalMedicinalProduct logical model.
Guidance on how to interpret the contents of this table can be found here
| 0. InvestigationalMedicinalProduct | |
| Definition | ISO 11615 Investigational Medicinal Product |
| Logical Model | Instances of this logical model are not marked to be the target of a Reference |
| 2. InvestigationalMedicinalProduct.IMPID | |
| Definition | The identifier for the Investigational Medicinal Product shall be always specified as text. (11.3.2.2.2) |
| Short | The identifier for the Investigational Medicinal Product shall be always specified as text. (11.3.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 4. InvestigationalMedicinalProduct.CombinedPharmaceuticalDoseForm | |
| Definition | The combined pharmaceutical dose form shall be specified, where applicable, as described in 9.2.2.2.3 . (11.3.2.2.3) |
| Short | The combined pharmaceutical dose form shall be specified, where applicable, as described in 9.2.2.2.3 . (11.3.2.2.3) |
| Control | 0..1 |
| Type | CodeableConcept |
| 6. InvestigationalMedicinalProduct.SponsorProductCode | |
| Definition | The product code (identifier) for the Investigational Medicinal Product as designated by the sponsor can be specified in text. Either this code or the regulator product code (see 1 1.3.2.2.5 ) shall be specified. (11.3.2.2.4) |
| Short | The product code (identifier) for the Investigational Medicinal Product as designated by the sponsor can be specified in text. Either this code or the regulator product code (see 1 1.3.2.2.5 ) shall be specified. (11.3.2.2.4) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 8. InvestigationalMedicinalProduct.RegulatorProductCode | |
| Definition | The product code (identifier) for the Investigational Medicinal Product as designated by the Medicines Regulatory Agency can be specified in text. Either this code or the sponsor product code (see 11.3. 2.2.4 ) shall be specified. (11.3.2.2.5) |
| Short | The product code (identifier) for the Investigational Medicinal Product as designated by the Medicines Regulatory Agency can be specified in text. Either this code or the sponsor product code (see 11.3. 2.2.4 ) shall be specified. (11.3.2.2.5) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 10. InvestigationalMedicinalProduct.PaediatricUseIndicator | |
| Definition | If the Investigational Medicinal Product refers to a specific paediatric formulation, this can be specified using a controlled vocabulary. A term and a term identifier shall be used. (11.3.2.2.6) |
| Short | If the Investigational Medicinal Product refers to a specific paediatric formulation, this can be specified using a controlled vocabulary. A term and a term identifier shall be used. (11.3.2.2.6) |
| Control | 0..1 |
| Type | CodeableConcept |
| 12. InvestigationalMedicinalProduct.ClinicalTrialStatus | |
| Definition | The status of the clinical trial has to be specified. See ISO / TS 20443 for more information and examples. (11.3.2.2.7) |
| Short | The status of the clinical trial has to be specified. See ISO / TS 20443 for more information and examples. (11.3.2.2.7) |
| Control | 0..1 |
| Type | CodeableConcept |
| 14. InvestigationalMedicinalProduct.OrphanDesignationStatus | |
| Definition | See 9.2.2.2.7 . (11.3.2.2.8) |
| Short | See 9.2.2.2.7 . (11.3.2.2.8) |
| Control | 0..1 |
| Type | CodeableConcept |
| 16. InvestigationalMedicinalProduct.AttachedDocument | |
| Definition | 11.3.2.6 |
| Short | 11.3.2.6 |
| Control | 1..* |
| Type | BackboneElement |
| 18. InvestigationalMedicinalProduct.AttachedDocument.Identifier | |
| Definition | The reference to the regulatory decision document related to the granting of the authorisation or the latest update of the regulated product information shall be specified in text. (9.2.2.11.2) |
| Short | The reference to the regulatory decision document related to the granting of the authorisation or the latest update of the regulated product information shall be specified in text. (9.2.2.11.2) |
| Control | 1..1 |
| Type | Identifier |
| 20. InvestigationalMedicinalProduct.AttachedDocument.EffectiveDate | |
| Definition | The date corresponding to a version of a regulated document containing regulated Medicinal Product information (e.g. elements related to the summary of product characteristics, product labelling). A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE Document version date corresponds to the tracking versions of a regulated document. It does not correspond to the actual revisions or regulatory timelines that may be captured within a regulated document. (9.2.2.11.3) |
| Short | The date corresponding to a version of a regulated document containing regulated Medicinal Product information (e.g. elements related to the summary of product characteristics, product labelling). A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE Document version date corresponds to the tracking versions of a regulated document. It does not correspond to the actual revisions or regulatory timelines that may be captured within a regulated document. (9.2.2.11.3) |
| Control | 1..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 22. InvestigationalMedicinalProduct.AttachedDocument.Type | |
| Definition | The type of document that is supporting a version increment shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.11.4) |
| Short | The type of document that is supporting a version increment shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.11.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 24. InvestigationalMedicinalProduct.AttachedDocument.Content | |
| Definition | The actual document that is supporting a version increment shall be attached. The format of the document attachment shall be specified by regional implementations. (9.2.2.11.5) |
| Short | The actual document that is supporting a version increment shall be attached. The format of the document attachment shall be specified by regional implementations. (9.2.2.11.5) |
| Control | 1..1 |
| Type | base64Binary |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 26. InvestigationalMedicinalProduct.AttachedDocument.Language | |
| Definition | This attribute defines the language used for the information related to the regulatory submission. (9.2.2.11.6) |
| Short | This attribute defines the language used for the information related to the regulatory submission. (9.2.2.11.6) |
| Control | 0..1 |
| Type | CodeableConcept |
| 28. InvestigationalMedicinalProduct.AttachedDocument.MediaType | |
| Definition | This attributes is used to define the graphic media type of the attached document. (9.2.2.11.7) |
| Short | This attributes is used to define the graphic media type of the attached document. (9.2.2.11.7) |
| Control | 0..1 |
| Type | CodeableConcept |
| 30. InvestigationalMedicinalProduct.AttachedDocument.VersionNumber | |
| Definition | This is a number identifying a specific version of the attached regulatory document. (9.2.2.11.8) |
| Short | This is a number identifying a specific version of the attached regulatory document. (9.2.2.11.8) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 32. InvestigationalMedicinalProduct.AttachedDocument.VersionSetIdentifier | |
| Definition | This is a number used to group together a set of specific versions of the same regulatory document. (9.2.2.11.9) |
| Short | This is a number used to group together a set of specific versions of the same regulatory document. (9.2.2.11.9) |
| Control | 0..1 |
| Type | Identifier |
| 34. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation | |
| Definition | 11.4.2.2 |
| Short | 11.4.2.2 |
| Control | 1..* |
| Type | BackboneElement |
| 36. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.RegistrationNumber | |
| Definition | The registration number (identifier) for a clinical trial in a region shall be specified. (11.4.2.2.2) |
| Short | The registration number (identifier) for a clinical trial in a region shall be specified. (11.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 38. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.InvestigationCode | |
| Definition | The code for a particular investigation (trial) as assigned in a jurisdiction for a clinical trial shall be specified in text. (11.4.2.2.3) |
| Short | The code for a particular investigation (trial) as assigned in a jurisdiction for a clinical trial shall be specified in text. (11.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 40. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Country | |
| Definition | The jurisdiction(s) in which the clinical trial authorisation was granted shall be described using ISO 3166 - 1 alpha-2 code elements. (11.4.2.2.4) |
| Short | The jurisdiction(s) in which the clinical trial authorisation was granted shall be described using ISO 3166 - 1 alpha-2 code elements. (11.4.2.2.4) |
| Control | 1..* |
| Type | CodeableConcept |
| 42. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.ProtocolNumber | |
| Definition | The number assigned to the clinical trial protocol shall be specified. (11.4.2.2.5) |
| Short | The number assigned to the clinical trial protocol shall be specified. (11.4.2.2.5) |
| Control | 1..1 |
| Type | Identifier |
| 44. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.AuthorisationDate | |
| Definition | The date when the clinical trial authorisation was granted by a Medicines Regulatory Agency in a jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.2.6) |
| Short | The date when the clinical trial authorisation was granted by a Medicines Regulatory Agency in a jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.2.6) |
| Control | 1..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 46. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.AnticipatedEndDate | |
| Definition | The date when the clinical trial is anticipated to be completed in accordance with the authorised clinical trial protocol in a jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.2.7) |
| Short | The date when the clinical trial is anticipated to be completed in accordance with the authorised clinical trial protocol in a jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.2.7) |
| Control | 1..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 48. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.LocalClinicalTrialAuthorisation | |
| Definition | 11.4.2.3 |
| Short | 11.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| 50. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.LocalClinicalTrialAuthorisation.LocalClinicalTrialRegistrationNumber | |
| Definition | The registration number (identifier) for a clinical trial as assigned by the Regulatory Medicines Authority locally shall be specified in text. (11.4.2.3.2) |
| Short | The registration number (identifier) for a clinical trial as assigned by the Regulatory Medicines Authority locally shall be specified in text. (11.4.2.3.2) |
| Control | 1..1 |
| Type | Identifier |
| 52. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.LocalClinicalTrialAuthorisation.LocalInvestigationCode | |
| Definition | The “code” for an Investigational Medicinal Product as assigned locally for a clinical trial of a set of clinical trials shall be specified in text. (11.4.2.3.3) |
| Short | The “code” for an Investigational Medicinal Product as assigned locally for a clinical trial of a set of clinical trials shall be specified in text. (11.4.2.3.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 54. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.LocalClinicalTrialAuthorisation.Jurisdiction | |
| Definition | The jurisdiction(s) in which the clinical trial authorisation was granted shall be described using ISO 3166 - 1 alpha-2 code elements. (11.4.2.3.4) |
| Short | The jurisdiction(s) in which the clinical trial authorisation was granted shall be described using ISO 3166 - 1 alpha-2 code elements. (11.4.2.3.4) |
| Control | 1..* |
| Type | CodeableConcept |
| 56. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.LocalClinicalTrialAuthorisation.LocalAuthorisationDate | |
| Definition | The date when the clinical trial authorisation was granted locally by a Regulatory Medicines Authority shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.3.5) |
| Short | The date when the clinical trial authorisation was granted locally by a Regulatory Medicines Authority shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.3.5) |
| Control | 1..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 58. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.LocalClinicalTrialAuthorisation.LocalAnticipatedEndDate | |
| Definition | The date when the clinical trial is anticipated to be completed in accordance with the authorised clinical trial protocol shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.3.6) |
| Short | The date when the clinical trial is anticipated to be completed in accordance with the authorised clinical trial protocol shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.3.6) |
| Control | 1..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 60. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation | |
| Definition | 9.3.2.5 |
| Short | 9.3.2.5 |
| Control | 1..1 |
| Type | BackboneElement |
| 62. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 64. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 66. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 68. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 70. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 72. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| 74. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 76. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 78. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 80. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 82. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| 84. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 86. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 88. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 90. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 92. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 94. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation | |
| Definition | 11.4.2.4 |
| Short | 11.4.2.4 |
| Control | 1..1 |
| Type | BackboneElement |
| 96. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 98. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 100. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 102. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 104. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 106. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| 108. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 110. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 112. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 114. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 116. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| 118. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 120. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 122. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 124. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 126. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 128. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.SME | |
| Definition | 9.3.2.4 |
| Short | 9.3.2.4 |
| Control | 0..1 |
| Type | BackboneElement |
| 130. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.SME.SMEFlag | |
| Definition | This is a flag to indicate if the organisation is an SME. (9.3.2.4.1) |
| Short | This is a flag to indicate if the organisation is an SME. (9.3.2.4.1) |
| Control | 1..1 |
| Type | Element(BL) |
| 132. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.SME.Size | |
| Definition | The size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2) |
| Short | The size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2) |
| Control | 0..1 |
| Type | CodeableConcept |
| 134. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.SME.SMENumber | |
| Definition | This is a unique number that it is uniquely identifying an SME. (9.3.2.4.3) |
| Short | This is a unique number that it is uniquely identifying an SME. (9.3.2.4.3) |
| Control | 0..1 |
| Type | Identifier |
| 136. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.SME.StatusDate | |
| Definition | This is the date when the SME status was granted. (9.3.2.4.4) |
| Short | This is the date when the SME status was granted. (9.3.2.4.4) |
| Control | 0..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 138. InvestigationalMedicinalProduct.Contraindication | |
| Definition | 9.9.2.3 |
| Short | 9.9.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| 140. InvestigationalMedicinalProduct.Contraindication.ContraindicationsText | |
| Definition | The text of the contraindication(s) in line with the regulated product information shall be described. (9.9.2.3.2) |
| Short | The text of the contraindication(s) in line with the regulated product information shall be described. (9.9.2.3.2) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 142. InvestigationalMedicinalProduct.Contraindication.ContraindicationsAsDisease-Symptom-Procedure | |
| Definition | The underlying disease, symptom or procedure of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.3) |
| Short | The underlying disease, symptom or procedure of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.3) |
| Control | 0..1 |
| Type | CodeableConcept |
| 144. InvestigationalMedicinalProduct.Contraindication.DiseaseStatus | |
| Definition | The status of the disease or symptom of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.4) |
| Short | The status of the disease or symptom of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.4) |
| Control | 0..1 |
| Type | CodeableConcept |
| 146. InvestigationalMedicinalProduct.Contraindication.Comorbidity | |
| Definition | The comorbidity (concurrent condition) or coinfection shall be specified. (9.9.2.3.5) |
| Short | The comorbidity (concurrent condition) or coinfection shall be specified. (9.9.2.3.5) |
| Control | 0..* |
| Type | CodeableConcept |
| 148. InvestigationalMedicinalProduct.Contraindication.OtherTherapySpecifics | |
| Definition | 9.9.2.6 |
| Short | 9.9.2.6 |
| Control | 0..* |
| Type | BackboneElement |
| 150. InvestigationalMedicinalProduct.Contraindication.OtherTherapySpecifics.TherapyRelationshipType | |
| Definition | The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2) |
| Short | The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 152. InvestigationalMedicinalProduct.Contraindication.OtherTherapySpecifics.Medication | |
| Definition | Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3) |
| Short | Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3) |
| Control | 1..1 |
| Type | CodeableConcept |
| 154. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics | |
| Definition | 9.9.2.5 |
| Short | 9.9.2.5 |
| Control | 0..* |
| Type | BackboneElement |
| 156. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics.Age | |
| Definition | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) |
| Short | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) |
| Control | 0..1 |
| Type | CodeableConcept |
| 158. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics.AgeRangeLow | |
| Definition | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) |
| Short | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) |
| Control | 0..1 |
| Type | Quantity |
| 160. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics.AgeRangeHigh | |
| Definition | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) |
| Short | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) |
| Control | 0..1 |
| Type | Quantity |
| 162. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics.Gender | |
| Definition | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) |
| Short | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 164. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics.Race | |
| Definition | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) |
| Short | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) |
| Control | 0..1 |
| Type | CodeableConcept |
| 166. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics.PhysiologicalCondition | |
| Definition | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) |
| Short | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) |
| Control | 0..1 |
| Type | CodeableConcept |
| 168. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication | |
| Definition | 9.9.2.2 |
| Short | 9.9.2.2 |
| Control | 0..* |
| Type | BackboneElement |
| 170. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.IndicationText | |
| Definition | The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2) |
| Short | The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 172. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.IndicationAsDisease-Symptom-Procedure | |
| Definition | The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3) |
| Short | The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3) |
| Control | 0..1 |
| Type | CodeableConcept |
| 174. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.DiseaseStatus | |
| Definition | The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4) |
| Short | The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4) |
| Control | 0..1 |
| Type | CodeableConcept |
| 176. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.Comorbidity | |
| Definition | If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5) |
| Short | If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5) |
| Control | 0..* |
| Type | CodeableConcept |
| 178. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.IntendedEffect | |
| Definition | The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6) |
| Short | The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6) |
| Control | 0..1 |
| Type | CodeableConcept |
| 180. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.Timing-Duration | |
| Definition | If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7) |
| Short | If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7) |
| Control | 0..1 |
| Type | Quantity |
| 182. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics | |
| Definition | 9.9.2.6 |
| Short | 9.9.2.6 |
| Control | 0..* |
| Type | BackboneElement |
| 184. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.TherapyRelationshipType | |
| Definition | The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2) |
| Short | The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 186. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.Medication | |
| Definition | Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3) |
| Short | Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3) |
| Control | 1..1 |
| Type | CodeableConcept |
| 188. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics | |
| Definition | 9.9.2.5 |
| Short | 9.9.2.5 |
| Control | 1..* |
| Type | BackboneElement |
| 190. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.Age | |
| Definition | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) |
| Short | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) |
| Control | 0..1 |
| Type | CodeableConcept |
| 192. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.AgeRangeLow | |
| Definition | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) |
| Short | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) |
| Control | 0..1 |
| Type | Quantity |
| 194. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.AgeRangeHigh | |
| Definition | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) |
| Short | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) |
| Control | 0..1 |
| Type | Quantity |
| 196. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.Gender | |
| Definition | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) |
| Short | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 198. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.Race | |
| Definition | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) |
| Short | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) |
| Control | 0..1 |
| Type | CodeableConcept |
| 200. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.PhysiologicalCondition | |
| Definition | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) |
| Short | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) |
| Control | 0..1 |
| Type | CodeableConcept |
| 202. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects | |
| Definition | 9.9.2.4 |
| Short | 9.9.2.4 |
| Control | 0..* |
| Type | BackboneElement |
| 204. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.UndesirableEffectText | |
| Definition | The text of the undesirable effect shall be given. (9.9.2.4.2) |
| Short | The text of the undesirable effect shall be given. (9.9.2.4.2) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 206. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.UndesirableEffectAsSymptom-Condition-Effect | |
| Definition | The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3) |
| Short | The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3) |
| Control | 0..1 |
| Type | CodeableConcept |
| 208. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.Symptom-Condition-EffectClassification | |
| Definition | The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4) |
| Short | The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4) |
| Control | 0..1 |
| Type | CodeableConcept |
| 210. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.FrequencyOfOccurrence | |
| Definition | The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5) |
| Short | The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 212. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics | |
| Definition | 9.9.2.5 |
| Short | 9.9.2.5 |
| Control | 0..* |
| Type | BackboneElement |
| 214. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Age | |
| Definition | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) |
| Short | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) |
| Control | 0..1 |
| Type | CodeableConcept |
| 216. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeLow | |
| Definition | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) |
| Short | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) |
| Control | 0..1 |
| Type | Quantity |
| 218. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeHigh | |
| Definition | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) |
| Short | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) |
| Control | 0..1 |
| Type | Quantity |
| 220. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Gender | |
| Definition | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) |
| Short | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 222. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Race | |
| Definition | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) |
| Short | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) |
| Control | 0..1 |
| Type | CodeableConcept |
| 224. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.PhysiologicalCondition | |
| Definition | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) |
| Short | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) |
| Control | 0..1 |
| Type | CodeableConcept |
| 226. InvestigationalMedicinalProduct.Header | |
| Definition | 11.3.2.5 |
| Short | 11.3.2.5 |
| Control | 1..1 |
| Type | BackboneElement |
| 228. InvestigationalMedicinalProduct.Header.Identifier | |
| Definition | This attribute is for the unique code identifying the regulatory information submission. (9.2.2.10.2) |
| Short | This attribute is for the unique code identifying the regulatory information submission. (9.2.2.10.2) |
| Control | 1..1 |
| Type | Identifier |
| 230. InvestigationalMedicinalProduct.Header.EffectiveDate | |
| Definition | The date specified in the regulatory decision document by which the authorisation or the updates to the regulated product information become effective shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.2.2.10.3) |
| Short | The date specified in the regulatory decision document by which the authorisation or the updates to the regulated product information become effective shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.2.2.10.3) |
| Control | 1..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 232. InvestigationalMedicinalProduct.Header.Language | |
| Definition | This attribute defines the language used for the information related to the regulatory submission. (9.2.2.10.4) |
| Short | This attribute defines the language used for the information related to the regulatory submission. (9.2.2.10.4) |
| Control | 0..1 |
| Type | CodeableConcept |
| 234. InvestigationalMedicinalProduct.Header.VersionNumber | |
| Definition | This is a number identifying a specific version of the regulatory information submission. (9.2.2.10.5) |
| Short | This is a number identifying a specific version of the regulatory information submission. (9.2.2.10.5) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 236. InvestigationalMedicinalProduct.Header.VersionSetIdentifier | |
| Definition | This is a number used to group together a set of specific versions of the regulatory information submission. (9.2.2.10.6) |
| Short | This is a number used to group together a set of specific versions of the regulatory information submission. (9.2.2.10.6) |
| Control | 0..1 |
| Type | Identifier |
| 238. InvestigationalMedicinalProduct.Interactions | |
| Definition | 9.9.2.7 |
| Short | 9.9.2.7 |
| Control | 0..* |
| Type | BackboneElement |
| 240. InvestigationalMedicinalProduct.Interactions.InteractionsText | |
| Definition | The text of the interaction in accordance with the regulated product information shall be provided. (9.9.2.7.2) |
| Short | The text of the interaction in accordance with the regulated product information shall be provided. (9.9.2.7.2) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 242. InvestigationalMedicinalProduct.Interactions.Interactant | |
| Definition | This element can be used to describe the specific medication, food or laboratory test that is the secondary interactant of the interaction as described in the regulated product information. For more information, refer to regional implementation guides. (9.9.2.7.3) |
| Short | This element can be used to describe the specific medication, food or laboratory test that is the secondary interactant of the interaction as described in the regulated product information. For more information, refer to regional implementation guides. (9.9.2.7.3) |
| Control | 0..* |
| Type | CodeableConcept |
| 244. InvestigationalMedicinalProduct.Interactions.InteractionsType | |
| Definition | The type of interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.4) |
| Short | The type of interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.4) |
| Control | 0..1 |
| Type | CodeableConcept |
| 246. InvestigationalMedicinalProduct.Interactions.InteractionsEffect | |
| Definition | The effect of the interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.5) |
| Short | The effect of the interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 248. InvestigationalMedicinalProduct.Interactions.InteractionsIncidence | |
| Definition | The incidence of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.6) |
| Short | The incidence of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.6) |
| Control | 0..1 |
| Type | CodeableConcept |
| 250. InvestigationalMedicinalProduct.Interactions.ManagementActions | |
| Definition | The actions to provide management of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.7) |
| Short | The actions to provide management of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.7) |
| Control | 0..1 |
| Type | CodeableConcept |
| 252. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName | |
| Definition | 11.3.2.8 |
| Short | 11.3.2.8 |
| Control | 1..1 |
| Type | BackboneElement |
| 254. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.FullName | |
| Definition | The full and complete Investigational Medicinal Product name as assigned by the sponsor can be specified as text. Unlike the authorised Medicinal Product name, this information is not mandatory for Investigational Medicinal Products, but either this attribute or the product code attribute below shall be valued. (11.3.2.8.1) |
| Short | The full and complete Investigational Medicinal Product name as assigned by the sponsor can be specified as text. Unlike the authorised Medicinal Product name, this information is not mandatory for Investigational Medicinal Products, but either this attribute or the product code attribute below shall be valued. (11.3.2.8.1) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 256. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.Code | |
| Definition | The Investigational Medicinal Product may, in its initial development, be described by an informal “code” rather than by name; this shall be specified here, where applicable. For all the other name part attributes, the information is as described previously in 9.2.2.8 . (11.3.2.8.2) |
| Short | The Investigational Medicinal Product may, in its initial development, be described by an informal “code” rather than by name; this shall be specified here, where applicable. For all the other name part attributes, the information is as described previously in 9.2.2.8 . (11.3.2.8.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 258. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.InventedNamePart | |
| Definition | The invented name (i.e. trade name) of the Medicinal Product without the trademark or any other similar designations reflected in the Medicinal Product name can be specified as text, where applicable. (9.2.2.8.3) |
| Short | The invented name (i.e. trade name) of the Medicinal Product without the trademark or any other similar designations reflected in the Medicinal Product name can be specified as text, where applicable. (9.2.2.8.3) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 260. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.ScientificNamePart | |
| Definition | The scientific or common (i.e. generic) name of the Medicinal Product without any other descriptors can be specified as text, where applicable. (9.2.2.8.4) |
| Short | The scientific or common (i.e. generic) name of the Medicinal Product without any other descriptors can be specified as text, where applicable. (9.2.2.8.4) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 262. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.StrengthPart | |
| Definition | The strength, if reflected in the Medicinal Product name, can be specified as text, where applicable. This strength name part can differ from the concept of “Strength” as described in 9.7 . (9.2.2.8.5) |
| Short | The strength, if reflected in the Medicinal Product name, can be specified as text, where applicable. This strength name part can differ from the concept of “Strength” as described in 9.7 . (9.2.2.8.5) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 264. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.PharmaceuticalDoseFormPart | |
| Definition | The pharmaceutical dose form, if reflected in the Medicinal Product name, can be specified as text, where applicable. This pharmaceutical dose form name part can differ from the concept of administrable dose form and manufactured dose form as described in ISO / TS 20443 . (9.2.2.8.6) |
| Short | The pharmaceutical dose form, if reflected in the Medicinal Product name, can be specified as text, where applicable. This pharmaceutical dose form name part can differ from the concept of administrable dose form and manufactured dose form as described in ISO / TS 20443 . (9.2.2.8.6) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 266. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.FormulationPart | |
| Definition | The formulation, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.7) |
| Short | The formulation, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.7) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 268. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.IntendedUsePart | |
| Definition | The intended use, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.8) |
| Short | The intended use, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.8) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 270. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.TargetPopulationPart | |
| Definition | The target population, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.9) |
| Short | The target population, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.9) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 272. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.ContainerOrPackPart | |
| Definition | The container or pack, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.10) |
| Short | The container or pack, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.10) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 274. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.DevicePart | |
| Definition | The device, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.11) |
| Short | The device, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.11) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 276. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.TrademarkOrCompanyNamePart | |
| Definition | The trademark, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.12) |
| Short | The trademark, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.12) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 278. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.Time-PeriodPart | |
| Definition | The time/period, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.13) |
| Short | The time/period, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.13) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 280. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.FlavourPart | |
| Definition | The flavour, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.14) |
| Short | The flavour, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.14) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 282. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.DelimiterPart | |
| Definition | A delimiter separates one composite in a segment from another or separates one subcomposite from another. (9.2.2.8.15) |
| Short | A delimiter separates one composite in a segment from another or separates one subcomposite from another. (9.2.2.8.15) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 284. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.Country-Language | |
| Definition | 9.2.2.9 |
| Short | 9.2.2.9 |
| Control | 1..* |
| Type | BackboneElement |
| 286. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.Country-Language.Country | |
| Definition | The country where the Medicinal Product name is applicable shall be described using ISO 3166 - 1 alpha-2 code elements. (9.2.2.9.2) |
| Short | The country where the Medicinal Product name is applicable shall be described using ISO 3166 - 1 alpha-2 code elements. (9.2.2.9.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 288. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.Country-Language.Jurisdiction | |
| Definition | The jurisdiction within the country where the Medicinal Product name is applicable can be described using an appropriate controlled vocabulary, if appropriate. The controlled term and the controlled term identifier shall be specified. (9.2.2.9.3) |
| Short | The jurisdiction within the country where the Medicinal Product name is applicable can be described using an appropriate controlled vocabulary, if appropriate. The controlled term and the controlled term identifier shall be specified. (9.2.2.9.3) |
| Control | 0..1 |
| Type | CodeableConcept |
| 290. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.Country-Language.Language | |
| Definition | The language of the Medicinal Product name as applicable in the specified country and jurisdiction if appropriate shall be specified using ISO 639 - 1 . (9.2.2.9.4) |
| Short | The language of the Medicinal Product name as applicable in the specified country and jurisdiction if appropriate shall be specified using ISO 639 - 1 . (9.2.2.9.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 292. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct | |
| Definition | 11.2.7 |
| Short | 11.2.7 |
| Control | 0..* |
| Type | BackboneElement |
| 294. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.IPCID | |
| Definition | This is the unique identifier for the Packaged Medicinal Product, constructed as described in 8.3 . (9.6.2.2.1) |
| Short | This is the unique identifier for the Packaged Medicinal Product, constructed as described in 8.3 . (9.6.2.2.1) |
| Control | 1..1 |
| Type | Identifier |
| 296. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageDescription | |
| Definition | A textual description of the Packaged Medicinal Product shall be provided. (9.6.2.2.2) |
| Short | A textual description of the Packaged Medicinal Product shall be provided. (9.6.2.2.2) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 298. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.BatchIdentifier | |
| Definition | 9.6.2.8 |
| Short | 9.6.2.8 |
| Control | 0..* |
| Type | BackboneElement |
| 300. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.BatchIdentifier.BAID1 | |
| Definition | The BAID1, which appears on the outer packaging of a specific batch of the Medicinal Product, shall be specified. Since there will be many different batches of any one Packaged Medicinal Product, and since the specification of batch identification might not always be required for each type of Packaged Medicinal Product, the cardinality of the relationship between the Packaged Medicinal Product and the batch identifier is given as 0...*. In situations where a Packaged Medicinal Product contains more than one manufactured item and/or includes a device, this batch number refers to the one given on the outermost packaging. (9.6.2.8.1) |
| Short | The BAID1, which appears on the outer packaging of a specific batch of the Medicinal Product, shall be specified. Since there will be many different batches of any one Packaged Medicinal Product, and since the specification of batch identification might not always be required for each type of Packaged Medicinal Product, the cardinality of the relationship between the Packaged Medicinal Product and the batch identifier is given as 0...*. In situations where a Packaged Medicinal Product contains more than one manufactured item and/or includes a device, this batch number refers to the one given on the outermost packaging. (9.6.2.8.1) |
| Control | 1..1 |
| Type | Identifier |
| 302. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.BatchIdentifier.BAID2 | |
| Definition | The BAID2, which appears on the immediate packaging and is not the outer packaging, shall be specified. (9.6.2.8.2) |
| Short | The BAID2, which appears on the immediate packaging and is not the outer packaging, shall be specified. (9.6.2.8.2) |
| Control | 0..1 |
| Type | Identifier |
| 304. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.BatchIdentifier.ExpirationDate | |
| Definition | This is the date the manufacturer guarantees the full potency and safety of a particular batch/lot of Medicinal Product. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.6.2.8.3) |
| Short | This is the date the manufacturer guarantees the full potency and safety of a particular batch/lot of Medicinal Product. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.6.2.8.3) |
| Control | 1..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 306. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation | |
| Definition | 9.5.2.2 |
| Short | 9.5.2.2 |
| Control | 0..* |
| Type | BackboneElement |
| 308. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 310. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 312. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 314. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 316. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 318. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| 320. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 322. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 324. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 326. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 328. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| 330. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 332. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 334. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 336. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 338. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 340. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation | |
| Definition | 9.5.2.3 |
| Short | 9.5.2.3 |
| Control | 1..* |
| Type | BackboneElement |
| 342. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType | |
| Definition | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Short | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 344. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber | |
| Definition | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Short | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Control | 0..1 |
| Type | Identifier |
| 346. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate | |
| Definition | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Short | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Control | 0..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 348. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator | |
| Definition | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Short | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 350. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation | |
| Definition | 9.3.2.5 |
| Short | 9.3.2.5 |
| Control | 0..1 |
| Type | BackboneElement |
| 352. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 354. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 356. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 358. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 360. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 362. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| 364. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 366. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 368. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 370. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 372. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| 374. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 376. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 378. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 380. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 382. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 384. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container | |
| Definition | 9.6.2.3 |
| Short | 9.6.2.3 |
| Control | 1..* |
| Type | BackboneElement |
| 386. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PackageItem-ContainerType | |
| Definition | The package item (container) type shall be specified to describe the physical type of the container of the medicine in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. A term and a term identifier shall be specified. (9.6.2.3.2) |
| Short | The package item (container) type shall be specified to describe the physical type of the container of the medicine in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. A term and a term identifier shall be specified. (9.6.2.3.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 388. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PackageItem-ContainerQuantity | |
| Definition | The quantity (or count number) of the package item shall be specified. Because the package item class recurses to describe containers within containers, the first (outermost) container shall always have a quantity of “1”. (9.6.2.3.3) |
| Short | The quantity (or count number) of the package item shall be specified. Because the package item class recurses to describe containers within containers, the first (outermost) container shall always have a quantity of “1”. (9.6.2.3.3) |
| Control | 1..1 |
| Type | Quantity |
| 390. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Material | |
| Definition | The material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology as applicable. A term and a term identifier shall be specified. (9.6.2.3.4) |
| Short | The material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology as applicable. A term and a term identifier shall be specified. (9.6.2.3.4) |
| Control | 1..* |
| Type | CodeableConcept |
| 392. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.AlternateMaterial | |
| Definition | The alternate material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 1 9844 and its resulting terminology as applicable. A term and a term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a blister sleeve). (9.6.2.3.5) |
| Short | The alternate material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 1 9844 and its resulting terminology as applicable. A term and a term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a blister sleeve). (9.6.2.3.5) |
| Control | 0..* |
| Type | CodeableConcept |
| 394. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier | |
| Definition | 9.6.2.4 |
| Short | 9.6.2.4 |
| Control | 0..* |
| Type | BackboneElement |
| 396. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier.CodeSystem | |
| Definition | The data carrier identification system itself shall be specified using an appropriate identification system. (9.6.2.4.2) |
| Short | The data carrier identification system itself shall be specified using an appropriate identification system. (9.6.2.4.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 398. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier.Value | |
| Definition | The individual value from the identification system that applies to the Packaged Medicinal Product shall be specified. (9.6.2.4.3) |
| Short | The individual value from the identification system that applies to the Packaged Medicinal Product shall be specified. (9.6.2.4.3) |
| Control | 1..1 |
| Type | CodeableConcept |
| 400. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device | |
| Definition | 9.6.2.12 |
| Short | 9.6.2.12 |
| Control | 0..* |
| Type | BackboneElement |
| 402. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceType | |
| Definition | The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2) |
| Short | The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 404. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceTradeName | |
| Definition | This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3) |
| Short | This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 406. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceQuantity | |
| Definition | The quantity of the device present in the pack shall be specified. (9.6.2.12.4) |
| Short | The quantity of the device present in the pack shall be specified. (9.6.2.12.4) |
| Control | 1..1 |
| Type | Quantity |
| 408. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceListingNumber | |
| Definition | This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5) |
| Short | This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 410. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceIdentifier | |
| Definition | A unique device identifier needs to be specified. (9.6.2.12.6) |
| Short | A unique device identifier needs to be specified. (9.6.2.12.6) |
| Control | 0..1 |
| Type | Identifier |
| 412. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.ModelNumber | |
| Definition | This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7) |
| Short | This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 414. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.SterilityIndicator | |
| Definition | Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8) |
| Short | Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8) |
| Control | 0..1 |
| Type | CodeableConcept |
| 416. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.SterilisationRequirementIndicator | |
| Definition | Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9) |
| Short | Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9) |
| Control | 0..1 |
| Type | CodeableConcept |
| 418. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceUsage | |
| Definition | The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10) |
| Short | The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10) |
| Control | 0..1 |
| Type | CodeableConcept |
| 420. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier | |
| Definition | 11.12 |
| Short | 11.12 |
| Control | 0..* |
| Type | BackboneElement |
| 422. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier.BatchNumber | |
| Definition | Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2) |
| Short | Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 424. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier.ExpirationDate | |
| Definition | Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3) |
| Short | Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3) |
| Control | 1..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 426. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial | |
| Definition | 9.6.2.13 |
| Short | 9.6.2.13 |
| Control | 0..* |
| Type | BackboneElement |
| 428. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.Substance | |
| Definition | The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2) |
| Short | The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 430. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.Alternate | |
| Definition | This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3) |
| Short | This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3) |
| Control | 0..1 |
| Type | Element(BL) |
| 432. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.AllergenicIndicator | |
| Definition | This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4) |
| Short | This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4) |
| Control | 0..1 |
| Type | Element(BL) |
| 434. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature | |
| Definition | 11.11 |
| Short | 11.11 |
| Control | 0..* |
| Type | BackboneElement |
| 436. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature.CodeSystem | |
| Definition | The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2) |
| Short | The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 438. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature.Value | |
| Definition | The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3) |
| Short | The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3) |
| Control | 1..1 |
| Type | CodeableConcept |
| 440. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation | |
| Definition | 9.5.2.2 |
| Short | 9.5.2.2 |
| Control | 0..1 |
| Type | BackboneElement |
| 442. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 444. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 446. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 448. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 450. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 452. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| 454. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 456. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 458. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 460. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 462. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| 464. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 466. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 468. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 470. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 472. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 474. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation | |
| Definition | 9.5.2.3 |
| Short | 9.5.2.3 |
| Control | 1..* |
| Type | BackboneElement |
| 476. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType | |
| Definition | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Short | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 478. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber | |
| Definition | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Short | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Control | 0..1 |
| Type | Identifier |
| 480. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate | |
| Definition | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Short | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Control | 0..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 482. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator | |
| Definition | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Short | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 484. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation | |
| Definition | 9.3.2.5 |
| Short | 9.3.2.5 |
| Control | 0..1 |
| Type | BackboneElement |
| 486. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 488. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 490. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 492. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 494. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 496. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| 498. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 500. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 502. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 504. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 506. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| 508. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 510. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 512. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 514. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 516. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 518. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics | |
| Definition | 9.6.2.22 |
| Short | 9.6.2.22 |
| Control | 0..* |
| Type | BackboneElement |
| 520. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics.CodeSystem | |
| Definition | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) |
| Short | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 522. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics.Value | |
| Definition | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) |
| Short | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) |
| Control | 1..1 |
| Type | CodeableConcept |
| 524. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics | |
| Definition | 11.13 |
| Short | 11.13 |
| Control | 0..1 |
| Type | BackboneElement |
| 526. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Height | |
| Definition | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) |
| Short | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) |
| Control | 0..1 |
| Type | Quantity |
| 528. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Width | |
| Definition | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) |
| Short | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) |
| Control | 0..1 |
| Type | Quantity |
| 530. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Depth | |
| Definition | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) |
| Short | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) |
| Control | 0..1 |
| Type | Quantity |
| 532. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Weight | |
| Definition | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) |
| Short | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) |
| Control | 0..1 |
| Type | Quantity |
| 534. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.NominalVolume | |
| Definition | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) |
| Short | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) |
| Control | 0..1 |
| Type | Quantity |
| 536. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.ExternalDiameter | |
| Definition | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) |
| Short | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) |
| Control | 0..1 |
| Type | Quantity |
| 538. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Shape | |
| Definition | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) |
| Short | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 540. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Colour | |
| Definition | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) |
| Short | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 542. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Imprint | |
| Definition | Where applicable, the imprint can be specified as text. (9.6.2.21.10) |
| Short | Where applicable, the imprint can be specified as text. (9.6.2.21.10) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 544. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Image | |
| Definition | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) |
| Short | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) |
| Control | 0..* |
| Type | base64Binary |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 546. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Scoring | |
| Definition | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) |
| Short | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) |
| Control | 0..1 |
| Type | CodeableConcept |
| 548. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage | |
| Definition | 9.6.2.11 |
| Short | 9.6.2.11 |
| Control | 0..* |
| Type | BackboneElement |
| 550. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.ShelfLifeType | |
| Definition | This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2) |
| Short | This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 552. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.ShelfLifeTimePeriod | |
| Definition | The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3) |
| Short | The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3) |
| Control | 1..1 |
| Type | Quantity |
| 554. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.SpecialPrecautionsForStorage | |
| Definition | Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4) |
| Short | Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4) |
| Control | 0..* |
| Type | CodeableConcept |
| 556. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem | |
| Definition | 9.6.2.20 |
| Short | 9.6.2.20 |
| Control | 0..* |
| Type | BackboneElement |
| 558. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.ManufacturedDoseForm | |
| Definition | This describes the pharmaceutical dose form of the manufactured item, where applicable, before transformation into the pharmaceutical product. The manufactured dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. A Medicinal Product may have two package items, e.g. one with a manufactured dose form of powder for solution for injection and the other with a manufactured dose form of solvent for solution for injection. These are then to be transformed to a solution for injection before the medicine can be administered to a patient. Powder and solvent for solution for injection is the “combined pharmaceutical dose form”, which is an attribute of “Medicinal Product” and solution for injection is the “administrable dose form”, which is an attribute of “pharmaceutical product”. (9.6.2.20.2) |
| Short | This describes the pharmaceutical dose form of the manufactured item, where applicable, before transformation into the pharmaceutical product. The manufactured dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. A Medicinal Product may have two package items, e.g. one with a manufactured dose form of powder for solution for injection and the other with a manufactured dose form of solvent for solution for injection. These are then to be transformed to a solution for injection before the medicine can be administered to a patient. Powder and solvent for solution for injection is the “combined pharmaceutical dose form”, which is an attribute of “Medicinal Product” and solution for injection is the “administrable dose form”, which is an attribute of “pharmaceutical product”. (9.6.2.20.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 560. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.UnitOfPresentation | |
| Definition | This specifies the “real world” units in which the quantity of the manufactured item is described. The unit of presentation can be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. For items where their quantity is a measured quantity of weight or volume, the “unit of presentation” shall not be given since it is the same as the units of that quantity (that is ml, mg or %). For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.3) |
| Short | This specifies the “real world” units in which the quantity of the manufactured item is described. The unit of presentation can be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. For items where their quantity is a measured quantity of weight or volume, the “unit of presentation” shall not be given since it is the same as the units of that quantity (that is ml, mg or %). For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.3) |
| Control | 0..1 |
| Type | CodeableConcept |
| 562. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.ManufacturedItemQuantity | |
| Definition | The quantity (or count number) of the manufactured item shall be described. It shall be specified as a value and units, and the units shall be specified as a symbol and a symbol identifier as defined in ISO 11240 and the resulting terminology. For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.4) |
| Short | The quantity (or count number) of the manufactured item shall be described. It shall be specified as a value and units, and the units shall be specified as a symbol and a symbol identifier as defined in ISO 11240 and the resulting terminology. For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.4) |
| Control | 1..1 |
| Type | Quantity |
| 564. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient | |
| Definition | 11.2.9 |
| Short | 11.2.9 |
| Control | 1..* |
| Type | BackboneElement |
| 566. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.IngredientRole | |
| Definition | The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2) |
| Short | The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 568. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.AllergenicIndicator | |
| Definition | This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3) |
| Short | This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3) |
| Control | 0..1 |
| Type | Element(BL) |
| 570. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation | |
| Definition | 9.5.2.2 |
| Short | 9.5.2.2 |
| Control | 0..* |
| Type | BackboneElement |
| 572. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 574. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 576. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 578. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 580. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 582. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| 584. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 586. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 588. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 590. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 592. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| 594. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 596. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 598. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 600. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 602. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 604. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation | |
| Definition | 9.5.2.3 |
| Short | 9.5.2.3 |
| Control | 1..* |
| Type | BackboneElement |
| 606. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType | |
| Definition | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Short | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 608. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber | |
| Definition | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Short | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Control | 0..1 |
| Type | Identifier |
| 610. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate | |
| Definition | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Short | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Control | 0..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 612. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator | |
| Definition | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Short | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 614. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation | |
| Definition | 9.3.2.5 |
| Short | 9.3.2.5 |
| Control | 0..1 |
| Type | BackboneElement |
| 616. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 618. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 620. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 622. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 624. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 626. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| 628. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 630. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 632. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 634. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 636. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| 638. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 640. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 642. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 644. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 646. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 648. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance | |
| Definition | 9.7.2.4 |
| Short | 9.7.2.4 |
| Control | 0..* |
| Type | BackboneElement |
| 650. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.SpecifiedSubstance | |
| Definition | When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2) |
| Short | When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 652. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.SpecifiedSubstanceGroup | |
| Definition | The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3) |
| Short | The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3) |
| Control | 1..1 |
| Type | CodeableConcept |
| 654. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.ConfidentialityIndicator | |
| Definition | The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4) |
| Short | The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4) |
| Control | 0..1 |
| Type | CodeableConcept |
| 656. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength | |
| Definition | 9.7.2.5 |
| Short | 9.7.2.5 |
| Control | 0..* |
| Type | BackboneElement |
| 658. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Strength-Presentation | |
| Definition | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) |
| Short | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) |
| Control | 1..1 |
| Type | Ratio |
| 660. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Strength-Concentration | |
| Definition | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) |
| Short | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) |
| Control | 0..1 |
| Type | Ratio |
| 662. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.MeasurementPoint | |
| Definition | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) |
| Short | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 664. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Country | |
| Definition | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) |
| Short | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) |
| Control | 0..* |
| Type | CodeableConcept |
| 666. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength | |
| Definition | 9.7.2.6 |
| Short | 9.7.2.6 |
| Control | 0..* |
| Type | BackboneElement |
| 668. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSubstance | |
| Definition | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) |
| Short | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) |
| Control | 0..1 |
| Type | CodeableConcept |
| 670. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance | |
| Definition | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) |
| Short | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) |
| Control | 0..1 |
| Type | CodeableConcept |
| 672. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrength | |
| Definition | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) |
| Short | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) |
| Control | 1..1 |
| Type | Ratio |
| 674. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint | |
| Definition | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) |
| Short | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 676. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthCountry | |
| Definition | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) |
| Short | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) |
| Control | 0..* |
| Type | CodeableConcept |
| 678. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance | |
| Definition | 9.7.2.3 |
| Short | 9.7.2.3 |
| Control | 0..1 |
| Type | BackboneElement |
| 680. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Substance | |
| Definition | A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2) |
| Short | A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 682. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength | |
| Definition | 9.7.2.5 |
| Short | 9.7.2.5 |
| Control | 1..* |
| Type | BackboneElement |
| 684. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.Strength-Presentation | |
| Definition | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) |
| Short | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) |
| Control | 1..1 |
| Type | Ratio |
| 686. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.Strength-Concentration | |
| Definition | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) |
| Short | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) |
| Control | 0..1 |
| Type | Ratio |
| 688. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.MeasurementPoint | |
| Definition | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) |
| Short | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 690. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.Country | |
| Definition | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) |
| Short | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) |
| Control | 0..* |
| Type | CodeableConcept |
| 692. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength | |
| Definition | 9.7.2.6 |
| Short | 9.7.2.6 |
| Control | 0..* |
| Type | BackboneElement |
| 694. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSubstance | |
| Definition | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) |
| Short | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) |
| Control | 0..1 |
| Type | CodeableConcept |
| 696. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance | |
| Definition | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) |
| Short | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) |
| Control | 0..1 |
| Type | CodeableConcept |
| 698. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrength | |
| Definition | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) |
| Short | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) |
| Control | 1..1 |
| Type | Ratio |
| 700. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint | |
| Definition | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) |
| Short | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 702. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthCountry | |
| Definition | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) |
| Short | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) |
| Control | 0..* |
| Type | CodeableConcept |
| 704. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation | |
| Definition | 9.5.2.2 |
| Short | 9.5.2.2 |
| Control | 0..* |
| Type | BackboneElement |
| 706. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 708. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 710. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 712. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 714. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 716. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| 718. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 720. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 722. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 724. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 726. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| 728. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 730. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 732. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 734. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 736. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 738. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation | |
| Definition | 9.5.2.3 |
| Short | 9.5.2.3 |
| Control | 1..* |
| Type | BackboneElement |
| 740. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType | |
| Definition | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Short | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 742. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber | |
| Definition | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Short | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Control | 0..1 |
| Type | Identifier |
| 744. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate | |
| Definition | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Short | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Control | 0..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 746. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator | |
| Definition | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Short | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 748. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation | |
| Definition | 9.3.2.5 |
| Short | 9.3.2.5 |
| Control | 0..1 |
| Type | BackboneElement |
| 750. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 752. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 754. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 756. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 758. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 760. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| 762. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 764. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 766. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 768. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 770. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| 772. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 774. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 776. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 778. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 780. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 782. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics | |
| Definition | 9.6.2.22 |
| Short | 9.6.2.22 |
| Control | 0..* |
| Type | BackboneElement |
| 784. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics.CodeSystem | |
| Definition | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) |
| Short | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 786. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics.Value | |
| Definition | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) |
| Short | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) |
| Control | 1..1 |
| Type | CodeableConcept |
| 788. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics | |
| Definition | 11.13 |
| Short | 11.13 |
| Control | 0..1 |
| Type | BackboneElement |
| 790. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Height | |
| Definition | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) |
| Short | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) |
| Control | 0..1 |
| Type | Quantity |
| 792. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Width | |
| Definition | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) |
| Short | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) |
| Control | 0..1 |
| Type | Quantity |
| 794. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Depth | |
| Definition | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) |
| Short | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) |
| Control | 0..1 |
| Type | Quantity |
| 796. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Weight | |
| Definition | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) |
| Short | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) |
| Control | 0..1 |
| Type | Quantity |
| 798. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.NominalVolume | |
| Definition | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) |
| Short | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) |
| Control | 0..1 |
| Type | Quantity |
| 800. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.ExternalDiameter | |
| Definition | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) |
| Short | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) |
| Control | 0..1 |
| Type | Quantity |
| 802. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Shape | |
| Definition | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) |
| Short | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 804. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Colour | |
| Definition | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) |
| Short | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 806. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Imprint | |
| Definition | Where applicable, the imprint can be specified as text. (9.6.2.21.10) |
| Short | Where applicable, the imprint can be specified as text. (9.6.2.21.10) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 808. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Image | |
| Definition | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) |
| Short | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) |
| Control | 0..* |
| Type | base64Binary |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 810. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Scoring | |
| Definition | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) |
| Short | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) |
| Control | 0..1 |
| Type | CodeableConcept |
| 812. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation | |
| Definition | 9.5.2.2 |
| Short | 9.5.2.2 |
| Control | 0..* |
| Type | BackboneElement |
| 814. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 816. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 818. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 820. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 822. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 824. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| 826. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 828. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 830. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 832. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 834. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| 836. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 838. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 840. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 842. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 844. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 846. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation | |
| Definition | 9.5.2.3 |
| Short | 9.5.2.3 |
| Control | 1..* |
| Type | BackboneElement |
| 848. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType | |
| Definition | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Short | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 850. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber | |
| Definition | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Short | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Control | 0..1 |
| Type | Identifier |
| 852. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate | |
| Definition | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Short | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Control | 0..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 854. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator | |
| Definition | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Short | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 856. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation | |
| Definition | 9.3.2.5 |
| Short | 9.3.2.5 |
| Control | 0..1 |
| Type | BackboneElement |
| 858. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 860. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 862. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 864. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 866. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 868. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| 870. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 872. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 874. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 876. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 878. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| 880. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 882. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 884. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 886. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 888. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 890. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics | |
| Definition | 9.6.2.22 |
| Short | 9.6.2.22 |
| Control | 0..* |
| Type | BackboneElement |
| 892. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics.CodeSystem | |
| Definition | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) |
| Short | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 894. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics.Value | |
| Definition | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) |
| Short | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) |
| Control | 1..1 |
| Type | CodeableConcept |
| 896. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component | |
| Definition | 9.6.2.9 |
| Short | 9.6.2.9 |
| Control | 0..* |
| Type | BackboneElement |
| 898. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.ComponentType | |
| Definition | The type of component whose material is being described may be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.9.2) |
| Short | The type of component whose material is being described may be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.9.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 900. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.ComponentMaterial | |
| Definition | The material(s) of the component can be specified. Materials may be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. (9.6.2.9.3) |
| Short | The material(s) of the component can be specified. Materials may be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. (9.6.2.9.3) |
| Control | 0..* |
| Type | CodeableConcept |
| 902. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.ComponentAlternateMaterial | |
| Definition | Alternative materials for the component can be specified. Materials shall be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of rubber for a stopper). (9.6.2.9.4) |
| Short | Alternative materials for the component can be specified. Materials shall be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of rubber for a stopper). (9.6.2.9.4) |
| Control | 0..* |
| Type | CodeableConcept |
| 904. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation | |
| Definition | 9.5.2.2 |
| Short | 9.5.2.2 |
| Control | 0..* |
| Type | BackboneElement |
| 906. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 908. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 910. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 912. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 914. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 916. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| 918. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 920. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 922. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 924. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 926. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| 928. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 930. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 932. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 934. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 936. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 938. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation | |
| Definition | 9.5.2.3 |
| Short | 9.5.2.3 |
| Control | 1..* |
| Type | BackboneElement |
| 940. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType | |
| Definition | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Short | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 942. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber | |
| Definition | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Short | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Control | 0..1 |
| Type | Identifier |
| 944. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate | |
| Definition | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Short | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Control | 0..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 946. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator | |
| Definition | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Short | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 948. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation | |
| Definition | 9.3.2.5 |
| Short | 9.3.2.5 |
| Control | 0..1 |
| Type | BackboneElement |
| 950. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 952. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 954. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 956. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 958. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 960. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| 962. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 964. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 966. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 968. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 970. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| 972. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 974. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 976. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 978. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 980. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 982. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics | |
| Definition | 11.13 |
| Short | 11.13 |
| Control | 0..1 |
| Type | BackboneElement |
| 984. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Height | |
| Definition | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) |
| Short | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) |
| Control | 0..1 |
| Type | Quantity |
| 986. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Width | |
| Definition | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) |
| Short | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) |
| Control | 0..1 |
| Type | Quantity |
| 988. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Depth | |
| Definition | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) |
| Short | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) |
| Control | 0..1 |
| Type | Quantity |
| 990. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Weight | |
| Definition | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) |
| Short | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) |
| Control | 0..1 |
| Type | Quantity |
| 992. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.NominalVolume | |
| Definition | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) |
| Short | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) |
| Control | 0..1 |
| Type | Quantity |
| 994. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.ExternalDiameter | |
| Definition | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) |
| Short | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) |
| Control | 0..1 |
| Type | Quantity |
| 996. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Shape | |
| Definition | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) |
| Short | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 998. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Colour | |
| Definition | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) |
| Short | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1000. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Imprint | |
| Definition | Where applicable, the imprint can be specified as text. (9.6.2.21.10) |
| Short | Where applicable, the imprint can be specified as text. (9.6.2.21.10) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1002. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Image | |
| Definition | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) |
| Short | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) |
| Control | 0..* |
| Type | base64Binary |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1004. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Scoring | |
| Definition | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) |
| Short | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1006. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics | |
| Definition | 11.13 |
| Short | 11.13 |
| Control | 0..1 |
| Type | BackboneElement |
| 1008. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Height | |
| Definition | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) |
| Short | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) |
| Control | 0..1 |
| Type | Quantity |
| 1010. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Width | |
| Definition | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) |
| Short | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) |
| Control | 0..1 |
| Type | Quantity |
| 1012. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Depth | |
| Definition | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) |
| Short | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) |
| Control | 0..1 |
| Type | Quantity |
| 1014. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Weight | |
| Definition | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) |
| Short | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) |
| Control | 0..1 |
| Type | Quantity |
| 1016. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.NominalVolume | |
| Definition | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) |
| Short | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) |
| Control | 0..1 |
| Type | Quantity |
| 1018. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.ExternalDiameter | |
| Definition | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) |
| Short | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) |
| Control | 0..1 |
| Type | Quantity |
| 1020. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Shape | |
| Definition | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) |
| Short | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1022. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Colour | |
| Definition | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) |
| Short | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1024. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Imprint | |
| Definition | Where applicable, the imprint can be specified as text. (9.6.2.21.10) |
| Short | Where applicable, the imprint can be specified as text. (9.6.2.21.10) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1026. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Image | |
| Definition | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) |
| Short | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) |
| Control | 0..* |
| Type | base64Binary |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1028. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Scoring | |
| Definition | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) |
| Short | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1030. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage | |
| Definition | 9.6.2.11 |
| Short | 9.6.2.11 |
| Control | 0..* |
| Type | BackboneElement |
| 1032. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.ShelfLifeType | |
| Definition | This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2) |
| Short | This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1034. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.ShelfLifeTimePeriod | |
| Definition | The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3) |
| Short | The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3) |
| Control | 1..1 |
| Type | Quantity |
| 1036. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.SpecialPrecautionsForStorage | |
| Definition | Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4) |
| Short | Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4) |
| Control | 0..* |
| Type | CodeableConcept |
| 1038. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation | |
| Definition | 9.5.2.2 |
| Short | 9.5.2.2 |
| Control | 0..* |
| Type | BackboneElement |
| 1040. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 1042. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1044. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 1046. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1048. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1050. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| 1052. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 1054. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 1056. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1058. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1060. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| 1062. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1064. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 1066. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1068. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 1070. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1072. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation | |
| Definition | 9.5.2.3 |
| Short | 9.5.2.3 |
| Control | 1..* |
| Type | BackboneElement |
| 1074. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType | |
| Definition | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Short | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1076. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber | |
| Definition | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Short | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Control | 0..1 |
| Type | Identifier |
| 1078. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate | |
| Definition | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Short | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Control | 0..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1080. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator | |
| Definition | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Short | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1082. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation | |
| Definition | 9.3.2.5 |
| Short | 9.3.2.5 |
| Control | 0..1 |
| Type | BackboneElement |
| 1084. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 1086. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1088. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 1090. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1092. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1094. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| 1096. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 1098. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 1100. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1102. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1104. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| 1106. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1108. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 1110. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1112. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 1114. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1116. InvestigationalMedicinalProduct.OrphanDesignation | |
| Definition | 9.2.2.3 |
| Short | 9.2.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| 1118. InvestigationalMedicinalProduct.OrphanDesignation.OrphanIndicationType | |
| Definition | This attribute is for the type of intended use of the Medicinal Product, for instance disease prevention, treatment or diagnostic. (9.2.2.3.2) |
| Short | This attribute is for the type of intended use of the Medicinal Product, for instance disease prevention, treatment or diagnostic. (9.2.2.3.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1120. InvestigationalMedicinalProduct.OrphanDesignation.OrphanProcedureNumber | |
| Definition | This attribute is the procedure number for the orphan designation authorisation application. (9.2.2.3.3) |
| Short | This attribute is the procedure number for the orphan designation authorisation application. (9.2.2.3.3) |
| Control | 0..1 |
| Type | Identifier |
| 1122. InvestigationalMedicinalProduct.OrphanDesignation.OrphanDesignationAuthorisationStatus | |
| Definition | This attribute is for describing the status of the orphan designation authorisation, for instance granted, pending, expired or withdrawn. (9.2.2.3.4) |
| Short | This attribute is for describing the status of the orphan designation authorisation, for instance granted, pending, expired or withdrawn. (9.2.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1124. InvestigationalMedicinalProduct.OrphanDesignation.OrphanDesignationAuthorisationDate | |
| Definition | This attribute is for the date in which the orphan designation status was granted. (9.2.2.3.5) |
| Short | This attribute is for the date in which the orphan designation status was granted. (9.2.2.3.5) |
| Control | 0..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1126. InvestigationalMedicinalProduct.OrphanDesignation.OrphanDesignationNumber | |
| Definition | This field is to indicate the orphan designation decision number. (9.2.2.3.6) |
| Short | This field is to indicate the orphan designation decision number. (9.2.2.3.6) |
| Control | 0..1 |
| Type | Identifier |
| 1128. InvestigationalMedicinalProduct.PharmaceuticalProduct | |
| Definition | 11.7.2 |
| Short | 11.7.2 |
| Control | 1..* |
| Type | BackboneElement |
| 1130. InvestigationalMedicinalProduct.PharmaceuticalProduct.AdministrableDoseForm | |
| Definition | This shall describe the administrable dose form in accordance with the regulated product information. This is after it has undergone any necessary reconstitution, where applicable. The administrable dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and the resulting terminology. The term and the term identifier shall be specified. In certain instances, the administrable dose form differs from the manufactured dose form when a transformation of the manufactured dose form has been carried out. The manufactured dose forms of two manufactured items are described as “powder for solution for injection” and “solvent for solution for injection” which after transformation correspond to the administrable dose form “solution for injection”. (9.8.2.2.2) |
| Short | This shall describe the administrable dose form in accordance with the regulated product information. This is after it has undergone any necessary reconstitution, where applicable. The administrable dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and the resulting terminology. The term and the term identifier shall be specified. In certain instances, the administrable dose form differs from the manufactured dose form when a transformation of the manufactured dose form has been carried out. The manufactured dose forms of two manufactured items are described as “powder for solution for injection” and “solvent for solution for injection” which after transformation correspond to the administrable dose form “solution for injection”. (9.8.2.2.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1132. InvestigationalMedicinalProduct.PharmaceuticalProduct.UnitOfPresentation | |
| Definition | The unit of presentation is a qualitative term describing the discrete unit in which a pharmaceutical product is presented to describe strength or quantity in cases where a quantitative unit of measurement is not appropriate. It is a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. For pharmaceutical products whose strength is measured as a quantity of weight or volume, the “unit of presentation” can be specified as the immediate (lowest level) container. For solid dose forms and other items whose strength is described on the basis of the amount in the unit of presentation, and which are counted in integer quantities, the unit for quantity shall be “1 unit” and the unit of presentation shall be the item that is counted, specified as a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. (9.8.2.2.3) |
| Short | The unit of presentation is a qualitative term describing the discrete unit in which a pharmaceutical product is presented to describe strength or quantity in cases where a quantitative unit of measurement is not appropriate. It is a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. For pharmaceutical products whose strength is measured as a quantity of weight or volume, the “unit of presentation” can be specified as the immediate (lowest level) container. For solid dose forms and other items whose strength is described on the basis of the amount in the unit of presentation, and which are counted in integer quantities, the unit for quantity shall be “1 unit” and the unit of presentation shall be the item that is counted, specified as a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. (9.8.2.2.3) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1134. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device | |
| Definition | 9.6.2.12 |
| Short | 9.6.2.12 |
| Control | 0..* |
| Type | BackboneElement |
| 1136. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceType | |
| Definition | The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2) |
| Short | The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1138. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceTradeName | |
| Definition | This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3) |
| Short | This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1140. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceQuantity | |
| Definition | The quantity of the device present in the pack shall be specified. (9.6.2.12.4) |
| Short | The quantity of the device present in the pack shall be specified. (9.6.2.12.4) |
| Control | 1..1 |
| Type | Quantity |
| 1142. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceListingNumber | |
| Definition | This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5) |
| Short | This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1144. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceIdentifier | |
| Definition | A unique device identifier needs to be specified. (9.6.2.12.6) |
| Short | A unique device identifier needs to be specified. (9.6.2.12.6) |
| Control | 0..1 |
| Type | Identifier |
| 1146. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.ModelNumber | |
| Definition | This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7) |
| Short | This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1148. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.SterilityIndicator | |
| Definition | Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8) |
| Short | Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1150. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.SterilisationRequirementIndicator | |
| Definition | Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9) |
| Short | Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1152. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceUsage | |
| Definition | The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10) |
| Short | The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1154. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier | |
| Definition | 11.12 |
| Short | 11.12 |
| Control | 0..* |
| Type | BackboneElement |
| 1156. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.BatchNumber | |
| Definition | Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2) |
| Short | Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1158. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.ExpirationDate | |
| Definition | Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3) |
| Short | Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3) |
| Control | 1..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1160. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial | |
| Definition | 9.6.2.13 |
| Short | 9.6.2.13 |
| Control | 0..* |
| Type | BackboneElement |
| 1162. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.Substance | |
| Definition | The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2) |
| Short | The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1164. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.Alternate | |
| Definition | This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3) |
| Short | This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3) |
| Control | 0..1 |
| Type | Element(BL) |
| 1166. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.AllergenicIndicator | |
| Definition | This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4) |
| Short | This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4) |
| Control | 0..1 |
| Type | Element(BL) |
| 1168. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature | |
| Definition | 11.11 |
| Short | 11.11 |
| Control | 0..* |
| Type | BackboneElement |
| 1170. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.CodeSystem | |
| Definition | The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2) |
| Short | The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1172. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.Value | |
| Definition | The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3) |
| Short | The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1174. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation | |
| Definition | 9.5.2.2 |
| Short | 9.5.2.2 |
| Control | 0..1 |
| Type | BackboneElement |
| 1176. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 1178. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1180. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 1182. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1184. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1186. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| 1188. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 1190. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 1192. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1194. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1196. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| 1198. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1200. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 1202. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1204. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 1206. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1208. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation | |
| Definition | 9.5.2.3 |
| Short | 9.5.2.3 |
| Control | 1..* |
| Type | BackboneElement |
| 1210. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType | |
| Definition | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Short | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1212. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber | |
| Definition | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Short | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Control | 0..1 |
| Type | Identifier |
| 1214. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate | |
| Definition | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Short | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Control | 0..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1216. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator | |
| Definition | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Short | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1218. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation | |
| Definition | 9.3.2.5 |
| Short | 9.3.2.5 |
| Control | 0..1 |
| Type | BackboneElement |
| 1220. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 1222. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1224. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 1226. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1228. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1230. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| 1232. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 1234. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 1236. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1238. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1240. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| 1242. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1244. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 1246. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1248. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 1250. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1252. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics | |
| Definition | 9.6.2.22 |
| Short | 9.6.2.22 |
| Control | 0..* |
| Type | BackboneElement |
| 1254. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.CodeSystem | |
| Definition | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) |
| Short | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1256. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.Value | |
| Definition | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) |
| Short | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1258. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics | |
| Definition | 11.13 |
| Short | 11.13 |
| Control | 0..1 |
| Type | BackboneElement |
| 1260. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Height | |
| Definition | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) |
| Short | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) |
| Control | 0..1 |
| Type | Quantity |
| 1262. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Width | |
| Definition | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) |
| Short | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) |
| Control | 0..1 |
| Type | Quantity |
| 1264. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Depth | |
| Definition | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) |
| Short | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) |
| Control | 0..1 |
| Type | Quantity |
| 1266. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Weight | |
| Definition | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) |
| Short | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) |
| Control | 0..1 |
| Type | Quantity |
| 1268. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.NominalVolume | |
| Definition | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) |
| Short | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) |
| Control | 0..1 |
| Type | Quantity |
| 1270. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.ExternalDiameter | |
| Definition | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) |
| Short | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) |
| Control | 0..1 |
| Type | Quantity |
| 1272. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Shape | |
| Definition | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) |
| Short | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1274. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Colour | |
| Definition | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) |
| Short | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1276. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Imprint | |
| Definition | Where applicable, the imprint can be specified as text. (9.6.2.21.10) |
| Short | Where applicable, the imprint can be specified as text. (9.6.2.21.10) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1278. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Image | |
| Definition | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) |
| Short | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) |
| Control | 0..* |
| Type | base64Binary |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1280. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Scoring | |
| Definition | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) |
| Short | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1282. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage | |
| Definition | 9.6.2.11 |
| Short | 9.6.2.11 |
| Control | 0..* |
| Type | BackboneElement |
| 1284. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.ShelfLifeType | |
| Definition | This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2) |
| Short | This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1286. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.ShelfLifeTimePeriod | |
| Definition | The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3) |
| Short | The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3) |
| Control | 1..1 |
| Type | Quantity |
| 1288. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.SpecialPrecautionsForStorage | |
| Definition | Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4) |
| Short | Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4) |
| Control | 0..* |
| Type | CodeableConcept |
| 1290. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration | |
| Definition | 11.7.3 |
| Short | 11.7.3 |
| Control | 1..* |
| Type | BackboneElement |
| 1292. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration.RouteOfAdministration | |
| Definition | (11.7.3.0) |
| Short | (11.7.3.0) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1294. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration.FirstDoseInHumans | |
| Definition | The first dose (dose quantity) administered in humans can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and symbol identifier shall be used. (11.7.3.2) |
| Short | The first dose (dose quantity) administered in humans can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and symbol identifier shall be used. (11.7.3.2) |
| Control | 0..1 |
| Type | Quantity |
| 1296. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration.MaximumSingleDose | |
| Definition | The maximum single dose (maximum single dose quantity) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.3) |
| Short | The maximum single dose (maximum single dose quantity) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.3) |
| Control | 0..1 |
| Type | Quantity |
| 1298. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration.MaximumDosePerDay | |
| Definition | The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.4) |
| Short | The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.4) |
| Control | 0..1 |
| Type | Quantity |
| 1300. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration.MaximumDosePerTreatmentPeriod | |
| Definition | The maximum dose per treatment period (maximum total dose quantity to be administered in the treatment period) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.5) |
| Short | The maximum dose per treatment period (maximum total dose quantity to be administered in the treatment period) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.5) |
| Control | 0..1 |
| Type | Ratio |
| 1302. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration.MaximumTreatmentPeriod | |
| Definition | The maximum treatment period during which the Investigational Medicinal Product can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of time measurement. The unit of time measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.6) |
| Short | The maximum treatment period during which the Investigational Medicinal Product can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of time measurement. The unit of time measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.6) |
| Control | 0..1 |
| Type | Quantity |
| 1304. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient | |
| Definition | 11.2.9 |
| Short | 11.2.9 |
| Control | 1..* |
| Type | BackboneElement |
| 1306. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.IngredientRole | |
| Definition | The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2) |
| Short | The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1308. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.AllergenicIndicator | |
| Definition | This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3) |
| Short | This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3) |
| Control | 0..1 |
| Type | Element(BL) |
| 1310. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation | |
| Definition | 9.5.2.2 |
| Short | 9.5.2.2 |
| Control | 0..* |
| Type | BackboneElement |
| 1312. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 1314. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1316. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 1318. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1320. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1322. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| 1324. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 1326. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 1328. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1330. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1332. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| 1334. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1336. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 1338. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1340. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 1342. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1344. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation | |
| Definition | 9.5.2.3 |
| Short | 9.5.2.3 |
| Control | 1..* |
| Type | BackboneElement |
| 1346. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType | |
| Definition | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Short | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1348. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber | |
| Definition | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Short | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Control | 0..1 |
| Type | Identifier |
| 1350. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate | |
| Definition | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Short | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Control | 0..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1352. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator | |
| Definition | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Short | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1354. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation | |
| Definition | 9.3.2.5 |
| Short | 9.3.2.5 |
| Control | 0..1 |
| Type | BackboneElement |
| 1356. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 1358. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1360. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 1362. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1364. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1366. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| 1368. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 1370. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 1372. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1374. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1376. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| 1378. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1380. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 1382. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1384. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 1386. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1388. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance | |
| Definition | 9.7.2.4 |
| Short | 9.7.2.4 |
| Control | 0..* |
| Type | BackboneElement |
| 1390. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.SpecifiedSubstance | |
| Definition | When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2) |
| Short | When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1392. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.SpecifiedSubstanceGroup | |
| Definition | The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3) |
| Short | The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1394. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.ConfidentialityIndicator | |
| Definition | The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4) |
| Short | The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1396. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength | |
| Definition | 9.7.2.5 |
| Short | 9.7.2.5 |
| Control | 0..* |
| Type | BackboneElement |
| 1398. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Strength-Presentation | |
| Definition | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) |
| Short | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) |
| Control | 1..1 |
| Type | Ratio |
| 1400. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Strength-Concentration | |
| Definition | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) |
| Short | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) |
| Control | 0..1 |
| Type | Ratio |
| 1402. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.MeasurementPoint | |
| Definition | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) |
| Short | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1404. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Country | |
| Definition | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) |
| Short | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) |
| Control | 0..* |
| Type | CodeableConcept |
| 1406. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength | |
| Definition | 9.7.2.6 |
| Short | 9.7.2.6 |
| Control | 0..* |
| Type | BackboneElement |
| 1408. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSubstance | |
| Definition | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) |
| Short | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1410. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance | |
| Definition | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) |
| Short | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1412. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrength | |
| Definition | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) |
| Short | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) |
| Control | 1..1 |
| Type | Ratio |
| 1414. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint | |
| Definition | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) |
| Short | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1416. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthCountry | |
| Definition | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) |
| Short | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) |
| Control | 0..* |
| Type | CodeableConcept |
| 1418. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance | |
| Definition | 9.7.2.3 |
| Short | 9.7.2.3 |
| Control | 0..1 |
| Type | BackboneElement |
| 1420. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Substance | |
| Definition | A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2) |
| Short | A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1422. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength | |
| Definition | 9.7.2.5 |
| Short | 9.7.2.5 |
| Control | 1..* |
| Type | BackboneElement |
| 1424. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Strength-Presentation | |
| Definition | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) |
| Short | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) |
| Control | 1..1 |
| Type | Ratio |
| 1426. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Strength-Concentration | |
| Definition | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) |
| Short | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) |
| Control | 0..1 |
| Type | Ratio |
| 1428. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.MeasurementPoint | |
| Definition | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) |
| Short | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1430. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Country | |
| Definition | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) |
| Short | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) |
| Control | 0..* |
| Type | CodeableConcept |
| 1432. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength | |
| Definition | 9.7.2.6 |
| Short | 9.7.2.6 |
| Control | 0..* |
| Type | BackboneElement |
| 1434. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSubstance | |
| Definition | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) |
| Short | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1436. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance | |
| Definition | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) |
| Short | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1438. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrength | |
| Definition | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) |
| Short | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) |
| Control | 1..1 |
| Type | Ratio |
| 1440. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint | |
| Definition | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) |
| Short | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1442. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthCountry | |
| Definition | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) |
| Short | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) |
| Control | 0..* |
| Type | CodeableConcept |
| 1444. InvestigationalMedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics | |
| Definition | 9.8.2.4 |
| Short | 9.8.2.4 |
| Control | 0..* |
| Type | BackboneElement |
| 1446. InvestigationalMedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.CodeSystem | |
| Definition | The code system being used to describe the type of characteristic shall be specified using an appropriate identification system. (9.8.2.4.2) |
| Short | The code system being used to describe the type of characteristic shall be specified using an appropriate identification system. (9.8.2.4.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1448. InvestigationalMedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.Value | |
| Definition | The individual value from the code system that describes the actual characteristic shall be specified using a controlled term and a controlled term identifier. (9.8.2.4.3) |
| Short | The individual value from the code system that describes the actual characteristic shall be specified using a controlled term and a controlled term identifier. (9.8.2.4.3) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1450. InvestigationalMedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.Status | |
| Definition | The status of the pharmaceutical product characteristic should be listed here, e.g. assigned, not assigned or pending. (9.8.2.4.4) |
| Short | The status of the pharmaceutical product characteristic should be listed here, e.g. assigned, not assigned or pending. (9.8.2.4.4) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1452. InvestigationalMedicinalProduct.PharmaceuticalProduct.PhPIDSet | |
| Definition | 9.8.2.6 |
| Short | 9.8.2.6 |
| Control | 1..* |
| Type | BackboneElement |
| 1454. InvestigationalMedicinalProduct.PharmaceuticalProduct.PhPIDSet.PhPIDIdentifierSets | |
| Definition | This class shall carry the relevant identifiers as defined by ISO 11616 and ISO / TS 20451 . This provides a uniform representation of the pharmaceutical product using the substance(s)/specified substance(s), their (reference) strength(s), the administrable dose form and, where applicable, the integral device. (9.8.2.6.0) |
| Short | This class shall carry the relevant identifiers as defined by ISO 11616 and ISO / TS 20451 . This provides a uniform representation of the pharmaceutical product using the substance(s)/specified substance(s), their (reference) strength(s), the administrable dose form and, where applicable, the integral device. (9.8.2.6.0) |
| Control | 1..1 |
| Type | Identifier |
| 1456. InvestigationalMedicinalProduct.ProductClassification | |
| Definition | 11.3.2.7 |
| Short | 11.3.2.7 |
| Control | 0..* |
| Type | BackboneElement |
| 1458. InvestigationalMedicinalProduct.ProductClassification.CodeSystem | |
| Definition | The Medicinal Product can be classified according to various classification systems, which may be regional, jurisdictional or international. The various classifications of the product can be specified in this subclause. The classification system shall be specified using an appropriate identification system; the controlled term and the controlled term identifier shall be specified. (9.2.2.4.2) |
| Short | The Medicinal Product can be classified according to various classification systems, which may be regional, jurisdictional or international. The various classifications of the product can be specified in this subclause. The classification system shall be specified using an appropriate identification system; the controlled term and the controlled term identifier shall be specified. (9.2.2.4.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1460. InvestigationalMedicinalProduct.ProductClassification.Value | |
| Definition | The individual value from the classification system that applies to the Medicinal Product shall be specified using a controlled term and a controlled term identifier. (9.2.2.4.3) |
| Short | The individual value from the classification system that applies to the Medicinal Product shall be specified using a controlled term and a controlled term identifier. (9.2.2.4.3) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1462. InvestigationalMedicinalProduct.ProductCross-Reference | |
| Definition | 11.3.2.4 |
| Short | 11.3.2.4 |
| Control | 0..* |
| Type | BackboneElement |
| 1464. InvestigationalMedicinalProduct.ProductCross-Reference.I-MPIDCross-Reference | |
| Definition | This is an attribute used to reference other IMPID(s) or MPID(s) related to the medicinal. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.2) |
| Short | This is an attribute used to reference other IMPID(s) or MPID(s) related to the medicinal. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.2) |
| Control | 1..1 |
| Type | Identifier |
| 1466. InvestigationalMedicinalProduct.ProductCross-Reference.ReferencedProductType | |
| Definition | This attribute is to identify which kind of Medicinal Product is cross-referenced. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.3) |
| Short | This attribute is to identify which kind of Medicinal Product is cross-referenced. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.3) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1468. InvestigationalMedicinalProduct.TherapeuticIndication | |
| Definition | 9.9.2.2 |
| Short | 9.9.2.2 |
| Control | 1..* |
| Type | BackboneElement |
| 1470. InvestigationalMedicinalProduct.TherapeuticIndication.IndicationText | |
| Definition | The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2) |
| Short | The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1472. InvestigationalMedicinalProduct.TherapeuticIndication.IndicationAsDisease-Symptom-Procedure | |
| Definition | The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3) |
| Short | The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1474. InvestigationalMedicinalProduct.TherapeuticIndication.DiseaseStatus | |
| Definition | The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4) |
| Short | The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1476. InvestigationalMedicinalProduct.TherapeuticIndication.Comorbidity | |
| Definition | If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5) |
| Short | If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5) |
| Control | 0..* |
| Type | CodeableConcept |
| 1478. InvestigationalMedicinalProduct.TherapeuticIndication.IntendedEffect | |
| Definition | The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6) |
| Short | The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1480. InvestigationalMedicinalProduct.TherapeuticIndication.Timing-Duration | |
| Definition | If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7) |
| Short | If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7) |
| Control | 0..1 |
| Type | Quantity |
| 1482. InvestigationalMedicinalProduct.TherapeuticIndication.OtherTherapySpecifics | |
| Definition | 9.9.2.6 |
| Short | 9.9.2.6 |
| Control | 0..* |
| Type | BackboneElement |
| 1484. InvestigationalMedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.TherapyRelationshipType | |
| Definition | The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2) |
| Short | The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1486. InvestigationalMedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.Medication | |
| Definition | Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3) |
| Short | Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1488. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics | |
| Definition | 9.9.2.5 |
| Short | 9.9.2.5 |
| Control | 1..* |
| Type | BackboneElement |
| 1490. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics.Age | |
| Definition | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) |
| Short | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1492. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics.AgeRangeLow | |
| Definition | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) |
| Short | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) |
| Control | 0..1 |
| Type | Quantity |
| 1494. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics.AgeRangeHigh | |
| Definition | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) |
| Short | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) |
| Control | 0..1 |
| Type | Quantity |
| 1496. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics.Gender | |
| Definition | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) |
| Short | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1498. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics.Race | |
| Definition | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) |
| Short | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1500. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics.PhysiologicalCondition | |
| Definition | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) |
| Short | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1502. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects | |
| Definition | 9.9.2.4 |
| Short | 9.9.2.4 |
| Control | 0..* |
| Type | BackboneElement |
| 1504. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.UndesirableEffectText | |
| Definition | The text of the undesirable effect shall be given. (9.9.2.4.2) |
| Short | The text of the undesirable effect shall be given. (9.9.2.4.2) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1506. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.UndesirableEffectAsSymptom-Condition-Effect | |
| Definition | The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3) |
| Short | The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1508. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.Symptom-Condition-EffectClassification | |
| Definition | The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4) |
| Short | The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1510. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.FrequencyOfOccurrence | |
| Definition | The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5) |
| Short | The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1512. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics | |
| Definition | 9.9.2.5 |
| Short | 9.9.2.5 |
| Control | 0..* |
| Type | BackboneElement |
| 1514. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Age | |
| Definition | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) |
| Short | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1516. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeLow | |
| Definition | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) |
| Short | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) |
| Control | 0..1 |
| Type | Quantity |
| 1518. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeHigh | |
| Definition | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) |
| Short | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) |
| Control | 0..1 |
| Type | Quantity |
| 1520. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Gender | |
| Definition | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) |
| Short | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1522. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Race | |
| Definition | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) |
| Short | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1524. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.PhysiologicalCondition | |
| Definition | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) |
| Short | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1526. InvestigationalMedicinalProduct.UndesirableEffects | |
| Definition | 9.9.2.4 |
| Short | 9.9.2.4 |
| Control | 0..* |
| Type | BackboneElement |
| 1528. InvestigationalMedicinalProduct.UndesirableEffects.UndesirableEffectText | |
| Definition | The text of the undesirable effect shall be given. (9.9.2.4.2) |
| Short | The text of the undesirable effect shall be given. (9.9.2.4.2) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1530. InvestigationalMedicinalProduct.UndesirableEffects.UndesirableEffectAsSymptom-Condition-Effect | |
| Definition | The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3) |
| Short | The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1532. InvestigationalMedicinalProduct.UndesirableEffects.Symptom-Condition-EffectClassification | |
| Definition | The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4) |
| Short | The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1534. InvestigationalMedicinalProduct.UndesirableEffects.FrequencyOfOccurrence | |
| Definition | The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5) |
| Short | The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1536. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics | |
| Definition | 9.9.2.5 |
| Short | 9.9.2.5 |
| Control | 0..* |
| Type | BackboneElement |
| 1538. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics.Age | |
| Definition | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) |
| Short | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1540. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics.AgeRangeLow | |
| Definition | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) |
| Short | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) |
| Control | 0..1 |
| Type | Quantity |
| 1542. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics.AgeRangeHigh | |
| Definition | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) |
| Short | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) |
| Control | 0..1 |
| Type | Quantity |
| 1544. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics.Gender | |
| Definition | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) |
| Short | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1546. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics.Race | |
| Definition | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) |
| Short | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1548. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics.PhysiologicalCondition | |
| Definition | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) |
| Short | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) |
| Control | 0..1 |
| Type | CodeableConcept |
Guidance on how to interpret the contents of this table can be found here
| 0. InvestigationalMedicinalProduct | |
| Definition | ISO 11615 Investigational Medicinal Product |
| Control | 0..* |
| Is Modifier | false |
| Logical Model | Instances of this logical model are not marked to be the target of a Reference |
| 2. InvestigationalMedicinalProduct.IMPID | |
| Definition | The identifier for the Investigational Medicinal Product shall be always specified as text. (11.3.2.2.2) |
| Short | The identifier for the Investigational Medicinal Product shall be always specified as text. (11.3.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 4. InvestigationalMedicinalProduct.CombinedPharmaceuticalDoseForm | |
| Definition | The combined pharmaceutical dose form shall be specified, where applicable, as described in 9.2.2.2.3 . (11.3.2.2.3) |
| Short | The combined pharmaceutical dose form shall be specified, where applicable, as described in 9.2.2.2.3 . (11.3.2.2.3) |
| Control | 0..1 |
| Type | CodeableConcept |
| 6. InvestigationalMedicinalProduct.SponsorProductCode | |
| Definition | The product code (identifier) for the Investigational Medicinal Product as designated by the sponsor can be specified in text. Either this code or the regulator product code (see 1 1.3.2.2.5 ) shall be specified. (11.3.2.2.4) |
| Short | The product code (identifier) for the Investigational Medicinal Product as designated by the sponsor can be specified in text. Either this code or the regulator product code (see 1 1.3.2.2.5 ) shall be specified. (11.3.2.2.4) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 8. InvestigationalMedicinalProduct.RegulatorProductCode | |
| Definition | The product code (identifier) for the Investigational Medicinal Product as designated by the Medicines Regulatory Agency can be specified in text. Either this code or the sponsor product code (see 11.3. 2.2.4 ) shall be specified. (11.3.2.2.5) |
| Short | The product code (identifier) for the Investigational Medicinal Product as designated by the Medicines Regulatory Agency can be specified in text. Either this code or the sponsor product code (see 11.3. 2.2.4 ) shall be specified. (11.3.2.2.5) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 10. InvestigationalMedicinalProduct.PaediatricUseIndicator | |
| Definition | If the Investigational Medicinal Product refers to a specific paediatric formulation, this can be specified using a controlled vocabulary. A term and a term identifier shall be used. (11.3.2.2.6) |
| Short | If the Investigational Medicinal Product refers to a specific paediatric formulation, this can be specified using a controlled vocabulary. A term and a term identifier shall be used. (11.3.2.2.6) |
| Control | 0..1 |
| Type | CodeableConcept |
| 12. InvestigationalMedicinalProduct.ClinicalTrialStatus | |
| Definition | The status of the clinical trial has to be specified. See ISO / TS 20443 for more information and examples. (11.3.2.2.7) |
| Short | The status of the clinical trial has to be specified. See ISO / TS 20443 for more information and examples. (11.3.2.2.7) |
| Control | 0..1 |
| Type | CodeableConcept |
| 14. InvestigationalMedicinalProduct.OrphanDesignationStatus | |
| Definition | See 9.2.2.2.7 . (11.3.2.2.8) |
| Short | See 9.2.2.2.7 . (11.3.2.2.8) |
| Control | 0..1 |
| Type | CodeableConcept |
| 16. InvestigationalMedicinalProduct.AttachedDocument | |
| Definition | 11.3.2.6 |
| Short | 11.3.2.6 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 18. InvestigationalMedicinalProduct.AttachedDocument.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 20. InvestigationalMedicinalProduct.AttachedDocument.Identifier | |
| Definition | The reference to the regulatory decision document related to the granting of the authorisation or the latest update of the regulated product information shall be specified in text. (9.2.2.11.2) |
| Short | The reference to the regulatory decision document related to the granting of the authorisation or the latest update of the regulated product information shall be specified in text. (9.2.2.11.2) |
| Control | 1..1 |
| Type | Identifier |
| 22. InvestigationalMedicinalProduct.AttachedDocument.EffectiveDate | |
| Definition | The date corresponding to a version of a regulated document containing regulated Medicinal Product information (e.g. elements related to the summary of product characteristics, product labelling). A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE Document version date corresponds to the tracking versions of a regulated document. It does not correspond to the actual revisions or regulatory timelines that may be captured within a regulated document. (9.2.2.11.3) |
| Short | The date corresponding to a version of a regulated document containing regulated Medicinal Product information (e.g. elements related to the summary of product characteristics, product labelling). A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE Document version date corresponds to the tracking versions of a regulated document. It does not correspond to the actual revisions or regulatory timelines that may be captured within a regulated document. (9.2.2.11.3) |
| Control | 1..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 24. InvestigationalMedicinalProduct.AttachedDocument.Type | |
| Definition | The type of document that is supporting a version increment shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.11.4) |
| Short | The type of document that is supporting a version increment shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.11.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 26. InvestigationalMedicinalProduct.AttachedDocument.Content | |
| Definition | The actual document that is supporting a version increment shall be attached. The format of the document attachment shall be specified by regional implementations. (9.2.2.11.5) |
| Short | The actual document that is supporting a version increment shall be attached. The format of the document attachment shall be specified by regional implementations. (9.2.2.11.5) |
| Control | 1..1 |
| Type | base64Binary |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 28. InvestigationalMedicinalProduct.AttachedDocument.Language | |
| Definition | This attribute defines the language used for the information related to the regulatory submission. (9.2.2.11.6) |
| Short | This attribute defines the language used for the information related to the regulatory submission. (9.2.2.11.6) |
| Control | 0..1 |
| Type | CodeableConcept |
| 30. InvestigationalMedicinalProduct.AttachedDocument.MediaType | |
| Definition | This attributes is used to define the graphic media type of the attached document. (9.2.2.11.7) |
| Short | This attributes is used to define the graphic media type of the attached document. (9.2.2.11.7) |
| Control | 0..1 |
| Type | CodeableConcept |
| 32. InvestigationalMedicinalProduct.AttachedDocument.VersionNumber | |
| Definition | This is a number identifying a specific version of the attached regulatory document. (9.2.2.11.8) |
| Short | This is a number identifying a specific version of the attached regulatory document. (9.2.2.11.8) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 34. InvestigationalMedicinalProduct.AttachedDocument.VersionSetIdentifier | |
| Definition | This is a number used to group together a set of specific versions of the same regulatory document. (9.2.2.11.9) |
| Short | This is a number used to group together a set of specific versions of the same regulatory document. (9.2.2.11.9) |
| Control | 0..1 |
| Type | Identifier |
| 36. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation | |
| Definition | 11.4.2.2 |
| Short | 11.4.2.2 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 38. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 40. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.RegistrationNumber | |
| Definition | The registration number (identifier) for a clinical trial in a region shall be specified. (11.4.2.2.2) |
| Short | The registration number (identifier) for a clinical trial in a region shall be specified. (11.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 42. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.InvestigationCode | |
| Definition | The code for a particular investigation (trial) as assigned in a jurisdiction for a clinical trial shall be specified in text. (11.4.2.2.3) |
| Short | The code for a particular investigation (trial) as assigned in a jurisdiction for a clinical trial shall be specified in text. (11.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 44. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Country | |
| Definition | The jurisdiction(s) in which the clinical trial authorisation was granted shall be described using ISO 3166 - 1 alpha-2 code elements. (11.4.2.2.4) |
| Short | The jurisdiction(s) in which the clinical trial authorisation was granted shall be described using ISO 3166 - 1 alpha-2 code elements. (11.4.2.2.4) |
| Control | 1..* |
| Type | CodeableConcept |
| 46. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.ProtocolNumber | |
| Definition | The number assigned to the clinical trial protocol shall be specified. (11.4.2.2.5) |
| Short | The number assigned to the clinical trial protocol shall be specified. (11.4.2.2.5) |
| Control | 1..1 |
| Type | Identifier |
| 48. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.AuthorisationDate | |
| Definition | The date when the clinical trial authorisation was granted by a Medicines Regulatory Agency in a jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.2.6) |
| Short | The date when the clinical trial authorisation was granted by a Medicines Regulatory Agency in a jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.2.6) |
| Control | 1..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 50. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.AnticipatedEndDate | |
| Definition | The date when the clinical trial is anticipated to be completed in accordance with the authorised clinical trial protocol in a jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.2.7) |
| Short | The date when the clinical trial is anticipated to be completed in accordance with the authorised clinical trial protocol in a jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.2.7) |
| Control | 1..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 52. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.LocalClinicalTrialAuthorisation | |
| Definition | 11.4.2.3 |
| Short | 11.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 54. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.LocalClinicalTrialAuthorisation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 56. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.LocalClinicalTrialAuthorisation.LocalClinicalTrialRegistrationNumber | |
| Definition | The registration number (identifier) for a clinical trial as assigned by the Regulatory Medicines Authority locally shall be specified in text. (11.4.2.3.2) |
| Short | The registration number (identifier) for a clinical trial as assigned by the Regulatory Medicines Authority locally shall be specified in text. (11.4.2.3.2) |
| Control | 1..1 |
| Type | Identifier |
| 58. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.LocalClinicalTrialAuthorisation.LocalInvestigationCode | |
| Definition | The “code” for an Investigational Medicinal Product as assigned locally for a clinical trial of a set of clinical trials shall be specified in text. (11.4.2.3.3) |
| Short | The “code” for an Investigational Medicinal Product as assigned locally for a clinical trial of a set of clinical trials shall be specified in text. (11.4.2.3.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 60. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.LocalClinicalTrialAuthorisation.Jurisdiction | |
| Definition | The jurisdiction(s) in which the clinical trial authorisation was granted shall be described using ISO 3166 - 1 alpha-2 code elements. (11.4.2.3.4) |
| Short | The jurisdiction(s) in which the clinical trial authorisation was granted shall be described using ISO 3166 - 1 alpha-2 code elements. (11.4.2.3.4) |
| Control | 1..* |
| Type | CodeableConcept |
| 62. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.LocalClinicalTrialAuthorisation.LocalAuthorisationDate | |
| Definition | The date when the clinical trial authorisation was granted locally by a Regulatory Medicines Authority shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.3.5) |
| Short | The date when the clinical trial authorisation was granted locally by a Regulatory Medicines Authority shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.3.5) |
| Control | 1..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 64. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.LocalClinicalTrialAuthorisation.LocalAnticipatedEndDate | |
| Definition | The date when the clinical trial is anticipated to be completed in accordance with the authorised clinical trial protocol shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.3.6) |
| Short | The date when the clinical trial is anticipated to be completed in accordance with the authorised clinical trial protocol shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.3.6) |
| Control | 1..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 66. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation | |
| Definition | 9.3.2.5 |
| Short | 9.3.2.5 |
| Control | 1..1 |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 68. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 70. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 72. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 74. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 76. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 78. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 80. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 82. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 84. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 86. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 88. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 90. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 92. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 94. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 96. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 98. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 100. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 102. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 104. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 106. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation | |
| Definition | 11.4.2.4 |
| Short | 11.4.2.4 |
| Control | 1..1 |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 108. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 110. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 112. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 114. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 116. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 118. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 120. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 122. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Contact.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 124. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 126. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 128. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 130. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 132. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 134. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.OtherLocations.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 136. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 138. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 140. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 142. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 144. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 146. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.SME | |
| Definition | 9.3.2.4 |
| Short | 9.3.2.4 |
| Control | 0..1 |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 148. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.SME.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 150. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.SME.SMEFlag | |
| Definition | This is a flag to indicate if the organisation is an SME. (9.3.2.4.1) |
| Short | This is a flag to indicate if the organisation is an SME. (9.3.2.4.1) |
| Control | 1..1 |
| Type | Element(BL) |
| 152. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.SME.Size | |
| Definition | The size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2) |
| Short | The size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2) |
| Control | 0..1 |
| Type | CodeableConcept |
| 154. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.SME.SMENumber | |
| Definition | This is a unique number that it is uniquely identifying an SME. (9.3.2.4.3) |
| Short | This is a unique number that it is uniquely identifying an SME. (9.3.2.4.3) |
| Control | 0..1 |
| Type | Identifier |
| 156. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.SME.StatusDate | |
| Definition | This is the date when the SME status was granted. (9.3.2.4.4) |
| Short | This is the date when the SME status was granted. (9.3.2.4.4) |
| Control | 0..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 158. InvestigationalMedicinalProduct.Contraindication | |
| Definition | 9.9.2.3 |
| Short | 9.9.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 160. InvestigationalMedicinalProduct.Contraindication.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 162. InvestigationalMedicinalProduct.Contraindication.ContraindicationsText | |
| Definition | The text of the contraindication(s) in line with the regulated product information shall be described. (9.9.2.3.2) |
| Short | The text of the contraindication(s) in line with the regulated product information shall be described. (9.9.2.3.2) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 164. InvestigationalMedicinalProduct.Contraindication.ContraindicationsAsDisease-Symptom-Procedure | |
| Definition | The underlying disease, symptom or procedure of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.3) |
| Short | The underlying disease, symptom or procedure of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.3) |
| Control | 0..1 |
| Type | CodeableConcept |
| 166. InvestigationalMedicinalProduct.Contraindication.DiseaseStatus | |
| Definition | The status of the disease or symptom of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.4) |
| Short | The status of the disease or symptom of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.4) |
| Control | 0..1 |
| Type | CodeableConcept |
| 168. InvestigationalMedicinalProduct.Contraindication.Comorbidity | |
| Definition | The comorbidity (concurrent condition) or coinfection shall be specified. (9.9.2.3.5) |
| Short | The comorbidity (concurrent condition) or coinfection shall be specified. (9.9.2.3.5) |
| Control | 0..* |
| Type | CodeableConcept |
| 170. InvestigationalMedicinalProduct.Contraindication.OtherTherapySpecifics | |
| Definition | 9.9.2.6 |
| Short | 9.9.2.6 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 172. InvestigationalMedicinalProduct.Contraindication.OtherTherapySpecifics.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 174. InvestigationalMedicinalProduct.Contraindication.OtherTherapySpecifics.TherapyRelationshipType | |
| Definition | The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2) |
| Short | The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 176. InvestigationalMedicinalProduct.Contraindication.OtherTherapySpecifics.Medication | |
| Definition | Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3) |
| Short | Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3) |
| Control | 1..1 |
| Type | CodeableConcept |
| 178. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics | |
| Definition | 9.9.2.5 |
| Short | 9.9.2.5 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 180. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 182. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics.Age | |
| Definition | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) |
| Short | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) |
| Control | 0..1 |
| Type | CodeableConcept |
| 184. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics.AgeRangeLow | |
| Definition | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) |
| Short | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) |
| Control | 0..1 |
| Type | Quantity |
| 186. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics.AgeRangeHigh | |
| Definition | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) |
| Short | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) |
| Control | 0..1 |
| Type | Quantity |
| 188. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics.Gender | |
| Definition | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) |
| Short | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 190. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics.Race | |
| Definition | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) |
| Short | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) |
| Control | 0..1 |
| Type | CodeableConcept |
| 192. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics.PhysiologicalCondition | |
| Definition | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) |
| Short | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) |
| Control | 0..1 |
| Type | CodeableConcept |
| 194. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication | |
| Definition | 9.9.2.2 |
| Short | 9.9.2.2 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 196. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 198. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.IndicationText | |
| Definition | The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2) |
| Short | The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 200. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.IndicationAsDisease-Symptom-Procedure | |
| Definition | The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3) |
| Short | The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3) |
| Control | 0..1 |
| Type | CodeableConcept |
| 202. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.DiseaseStatus | |
| Definition | The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4) |
| Short | The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4) |
| Control | 0..1 |
| Type | CodeableConcept |
| 204. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.Comorbidity | |
| Definition | If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5) |
| Short | If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5) |
| Control | 0..* |
| Type | CodeableConcept |
| 206. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.IntendedEffect | |
| Definition | The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6) |
| Short | The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6) |
| Control | 0..1 |
| Type | CodeableConcept |
| 208. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.Timing-Duration | |
| Definition | If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7) |
| Short | If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7) |
| Control | 0..1 |
| Type | Quantity |
| 210. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics | |
| Definition | 9.9.2.6 |
| Short | 9.9.2.6 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 212. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 214. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.TherapyRelationshipType | |
| Definition | The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2) |
| Short | The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 216. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.Medication | |
| Definition | Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3) |
| Short | Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3) |
| Control | 1..1 |
| Type | CodeableConcept |
| 218. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics | |
| Definition | 9.9.2.5 |
| Short | 9.9.2.5 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 220. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 222. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.Age | |
| Definition | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) |
| Short | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) |
| Control | 0..1 |
| Type | CodeableConcept |
| 224. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.AgeRangeLow | |
| Definition | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) |
| Short | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) |
| Control | 0..1 |
| Type | Quantity |
| 226. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.AgeRangeHigh | |
| Definition | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) |
| Short | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) |
| Control | 0..1 |
| Type | Quantity |
| 228. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.Gender | |
| Definition | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) |
| Short | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 230. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.Race | |
| Definition | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) |
| Short | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) |
| Control | 0..1 |
| Type | CodeableConcept |
| 232. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.PhysiologicalCondition | |
| Definition | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) |
| Short | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) |
| Control | 0..1 |
| Type | CodeableConcept |
| 234. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects | |
| Definition | 9.9.2.4 |
| Short | 9.9.2.4 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 236. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 238. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.UndesirableEffectText | |
| Definition | The text of the undesirable effect shall be given. (9.9.2.4.2) |
| Short | The text of the undesirable effect shall be given. (9.9.2.4.2) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 240. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.UndesirableEffectAsSymptom-Condition-Effect | |
| Definition | The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3) |
| Short | The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3) |
| Control | 0..1 |
| Type | CodeableConcept |
| 242. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.Symptom-Condition-EffectClassification | |
| Definition | The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4) |
| Short | The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4) |
| Control | 0..1 |
| Type | CodeableConcept |
| 244. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.FrequencyOfOccurrence | |
| Definition | The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5) |
| Short | The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 246. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics | |
| Definition | 9.9.2.5 |
| Short | 9.9.2.5 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 248. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 250. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Age | |
| Definition | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) |
| Short | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) |
| Control | 0..1 |
| Type | CodeableConcept |
| 252. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeLow | |
| Definition | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) |
| Short | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) |
| Control | 0..1 |
| Type | Quantity |
| 254. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeHigh | |
| Definition | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) |
| Short | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) |
| Control | 0..1 |
| Type | Quantity |
| 256. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Gender | |
| Definition | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) |
| Short | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 258. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Race | |
| Definition | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) |
| Short | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) |
| Control | 0..1 |
| Type | CodeableConcept |
| 260. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.PhysiologicalCondition | |
| Definition | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) |
| Short | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) |
| Control | 0..1 |
| Type | CodeableConcept |
| 262. InvestigationalMedicinalProduct.Header | |
| Definition | 11.3.2.5 |
| Short | 11.3.2.5 |
| Control | 1..1 |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 264. InvestigationalMedicinalProduct.Header.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 266. InvestigationalMedicinalProduct.Header.Identifier | |
| Definition | This attribute is for the unique code identifying the regulatory information submission. (9.2.2.10.2) |
| Short | This attribute is for the unique code identifying the regulatory information submission. (9.2.2.10.2) |
| Control | 1..1 |
| Type | Identifier |
| 268. InvestigationalMedicinalProduct.Header.EffectiveDate | |
| Definition | The date specified in the regulatory decision document by which the authorisation or the updates to the regulated product information become effective shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.2.2.10.3) |
| Short | The date specified in the regulatory decision document by which the authorisation or the updates to the regulated product information become effective shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.2.2.10.3) |
| Control | 1..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 270. InvestigationalMedicinalProduct.Header.Language | |
| Definition | This attribute defines the language used for the information related to the regulatory submission. (9.2.2.10.4) |
| Short | This attribute defines the language used for the information related to the regulatory submission. (9.2.2.10.4) |
| Control | 0..1 |
| Type | CodeableConcept |
| 272. InvestigationalMedicinalProduct.Header.VersionNumber | |
| Definition | This is a number identifying a specific version of the regulatory information submission. (9.2.2.10.5) |
| Short | This is a number identifying a specific version of the regulatory information submission. (9.2.2.10.5) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 274. InvestigationalMedicinalProduct.Header.VersionSetIdentifier | |
| Definition | This is a number used to group together a set of specific versions of the regulatory information submission. (9.2.2.10.6) |
| Short | This is a number used to group together a set of specific versions of the regulatory information submission. (9.2.2.10.6) |
| Control | 0..1 |
| Type | Identifier |
| 276. InvestigationalMedicinalProduct.Interactions | |
| Definition | 9.9.2.7 |
| Short | 9.9.2.7 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 278. InvestigationalMedicinalProduct.Interactions.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 280. InvestigationalMedicinalProduct.Interactions.InteractionsText | |
| Definition | The text of the interaction in accordance with the regulated product information shall be provided. (9.9.2.7.2) |
| Short | The text of the interaction in accordance with the regulated product information shall be provided. (9.9.2.7.2) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 282. InvestigationalMedicinalProduct.Interactions.Interactant | |
| Definition | This element can be used to describe the specific medication, food or laboratory test that is the secondary interactant of the interaction as described in the regulated product information. For more information, refer to regional implementation guides. (9.9.2.7.3) |
| Short | This element can be used to describe the specific medication, food or laboratory test that is the secondary interactant of the interaction as described in the regulated product information. For more information, refer to regional implementation guides. (9.9.2.7.3) |
| Control | 0..* |
| Type | CodeableConcept |
| 284. InvestigationalMedicinalProduct.Interactions.InteractionsType | |
| Definition | The type of interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.4) |
| Short | The type of interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.4) |
| Control | 0..1 |
| Type | CodeableConcept |
| 286. InvestigationalMedicinalProduct.Interactions.InteractionsEffect | |
| Definition | The effect of the interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.5) |
| Short | The effect of the interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 288. InvestigationalMedicinalProduct.Interactions.InteractionsIncidence | |
| Definition | The incidence of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.6) |
| Short | The incidence of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.6) |
| Control | 0..1 |
| Type | CodeableConcept |
| 290. InvestigationalMedicinalProduct.Interactions.ManagementActions | |
| Definition | The actions to provide management of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.7) |
| Short | The actions to provide management of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.7) |
| Control | 0..1 |
| Type | CodeableConcept |
| 292. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName | |
| Definition | 11.3.2.8 |
| Short | 11.3.2.8 |
| Control | 1..1 |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 294. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 296. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.FullName | |
| Definition | The full and complete Investigational Medicinal Product name as assigned by the sponsor can be specified as text. Unlike the authorised Medicinal Product name, this information is not mandatory for Investigational Medicinal Products, but either this attribute or the product code attribute below shall be valued. (11.3.2.8.1) |
| Short | The full and complete Investigational Medicinal Product name as assigned by the sponsor can be specified as text. Unlike the authorised Medicinal Product name, this information is not mandatory for Investigational Medicinal Products, but either this attribute or the product code attribute below shall be valued. (11.3.2.8.1) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 298. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.Code | |
| Definition | The Investigational Medicinal Product may, in its initial development, be described by an informal “code” rather than by name; this shall be specified here, where applicable. For all the other name part attributes, the information is as described previously in 9.2.2.8 . (11.3.2.8.2) |
| Short | The Investigational Medicinal Product may, in its initial development, be described by an informal “code” rather than by name; this shall be specified here, where applicable. For all the other name part attributes, the information is as described previously in 9.2.2.8 . (11.3.2.8.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 300. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.InventedNamePart | |
| Definition | The invented name (i.e. trade name) of the Medicinal Product without the trademark or any other similar designations reflected in the Medicinal Product name can be specified as text, where applicable. (9.2.2.8.3) |
| Short | The invented name (i.e. trade name) of the Medicinal Product without the trademark or any other similar designations reflected in the Medicinal Product name can be specified as text, where applicable. (9.2.2.8.3) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 302. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.ScientificNamePart | |
| Definition | The scientific or common (i.e. generic) name of the Medicinal Product without any other descriptors can be specified as text, where applicable. (9.2.2.8.4) |
| Short | The scientific or common (i.e. generic) name of the Medicinal Product without any other descriptors can be specified as text, where applicable. (9.2.2.8.4) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 304. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.StrengthPart | |
| Definition | The strength, if reflected in the Medicinal Product name, can be specified as text, where applicable. This strength name part can differ from the concept of “Strength” as described in 9.7 . (9.2.2.8.5) |
| Short | The strength, if reflected in the Medicinal Product name, can be specified as text, where applicable. This strength name part can differ from the concept of “Strength” as described in 9.7 . (9.2.2.8.5) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 306. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.PharmaceuticalDoseFormPart | |
| Definition | The pharmaceutical dose form, if reflected in the Medicinal Product name, can be specified as text, where applicable. This pharmaceutical dose form name part can differ from the concept of administrable dose form and manufactured dose form as described in ISO / TS 20443 . (9.2.2.8.6) |
| Short | The pharmaceutical dose form, if reflected in the Medicinal Product name, can be specified as text, where applicable. This pharmaceutical dose form name part can differ from the concept of administrable dose form and manufactured dose form as described in ISO / TS 20443 . (9.2.2.8.6) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 308. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.FormulationPart | |
| Definition | The formulation, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.7) |
| Short | The formulation, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.7) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 310. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.IntendedUsePart | |
| Definition | The intended use, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.8) |
| Short | The intended use, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.8) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 312. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.TargetPopulationPart | |
| Definition | The target population, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.9) |
| Short | The target population, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.9) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 314. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.ContainerOrPackPart | |
| Definition | The container or pack, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.10) |
| Short | The container or pack, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.10) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 316. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.DevicePart | |
| Definition | The device, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.11) |
| Short | The device, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.11) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 318. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.TrademarkOrCompanyNamePart | |
| Definition | The trademark, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.12) |
| Short | The trademark, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.12) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 320. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.Time-PeriodPart | |
| Definition | The time/period, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.13) |
| Short | The time/period, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.13) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 322. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.FlavourPart | |
| Definition | The flavour, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.14) |
| Short | The flavour, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.14) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 324. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.DelimiterPart | |
| Definition | A delimiter separates one composite in a segment from another or separates one subcomposite from another. (9.2.2.8.15) |
| Short | A delimiter separates one composite in a segment from another or separates one subcomposite from another. (9.2.2.8.15) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 326. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.Country-Language | |
| Definition | 9.2.2.9 |
| Short | 9.2.2.9 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 328. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.Country-Language.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 330. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.Country-Language.Country | |
| Definition | The country where the Medicinal Product name is applicable shall be described using ISO 3166 - 1 alpha-2 code elements. (9.2.2.9.2) |
| Short | The country where the Medicinal Product name is applicable shall be described using ISO 3166 - 1 alpha-2 code elements. (9.2.2.9.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 332. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.Country-Language.Jurisdiction | |
| Definition | The jurisdiction within the country where the Medicinal Product name is applicable can be described using an appropriate controlled vocabulary, if appropriate. The controlled term and the controlled term identifier shall be specified. (9.2.2.9.3) |
| Short | The jurisdiction within the country where the Medicinal Product name is applicable can be described using an appropriate controlled vocabulary, if appropriate. The controlled term and the controlled term identifier shall be specified. (9.2.2.9.3) |
| Control | 0..1 |
| Type | CodeableConcept |
| 334. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.Country-Language.Language | |
| Definition | The language of the Medicinal Product name as applicable in the specified country and jurisdiction if appropriate shall be specified using ISO 639 - 1 . (9.2.2.9.4) |
| Short | The language of the Medicinal Product name as applicable in the specified country and jurisdiction if appropriate shall be specified using ISO 639 - 1 . (9.2.2.9.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 336. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct | |
| Definition | 11.2.7 |
| Short | 11.2.7 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 338. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 340. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.IPCID | |
| Definition | This is the unique identifier for the Packaged Medicinal Product, constructed as described in 8.3 . (9.6.2.2.1) |
| Short | This is the unique identifier for the Packaged Medicinal Product, constructed as described in 8.3 . (9.6.2.2.1) |
| Control | 1..1 |
| Type | Identifier |
| 342. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageDescription | |
| Definition | A textual description of the Packaged Medicinal Product shall be provided. (9.6.2.2.2) |
| Short | A textual description of the Packaged Medicinal Product shall be provided. (9.6.2.2.2) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 344. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.BatchIdentifier | |
| Definition | 9.6.2.8 |
| Short | 9.6.2.8 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 346. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.BatchIdentifier.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 348. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.BatchIdentifier.BAID1 | |
| Definition | The BAID1, which appears on the outer packaging of a specific batch of the Medicinal Product, shall be specified. Since there will be many different batches of any one Packaged Medicinal Product, and since the specification of batch identification might not always be required for each type of Packaged Medicinal Product, the cardinality of the relationship between the Packaged Medicinal Product and the batch identifier is given as 0...*. In situations where a Packaged Medicinal Product contains more than one manufactured item and/or includes a device, this batch number refers to the one given on the outermost packaging. (9.6.2.8.1) |
| Short | The BAID1, which appears on the outer packaging of a specific batch of the Medicinal Product, shall be specified. Since there will be many different batches of any one Packaged Medicinal Product, and since the specification of batch identification might not always be required for each type of Packaged Medicinal Product, the cardinality of the relationship between the Packaged Medicinal Product and the batch identifier is given as 0...*. In situations where a Packaged Medicinal Product contains more than one manufactured item and/or includes a device, this batch number refers to the one given on the outermost packaging. (9.6.2.8.1) |
| Control | 1..1 |
| Type | Identifier |
| 350. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.BatchIdentifier.BAID2 | |
| Definition | The BAID2, which appears on the immediate packaging and is not the outer packaging, shall be specified. (9.6.2.8.2) |
| Short | The BAID2, which appears on the immediate packaging and is not the outer packaging, shall be specified. (9.6.2.8.2) |
| Control | 0..1 |
| Type | Identifier |
| 352. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.BatchIdentifier.ExpirationDate | |
| Definition | This is the date the manufacturer guarantees the full potency and safety of a particular batch/lot of Medicinal Product. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.6.2.8.3) |
| Short | This is the date the manufacturer guarantees the full potency and safety of a particular batch/lot of Medicinal Product. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.6.2.8.3) |
| Control | 1..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 354. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation | |
| Definition | 9.5.2.2 |
| Short | 9.5.2.2 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 356. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 358. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 360. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 362. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 364. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 366. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 368. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 370. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 372. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 374. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 376. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 378. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 380. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 382. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 384. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 386. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 388. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 390. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 392. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 394. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation | |
| Definition | 9.5.2.3 |
| Short | 9.5.2.3 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 396. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 398. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType | |
| Definition | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Short | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 400. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber | |
| Definition | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Short | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Control | 0..1 |
| Type | Identifier |
| 402. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate | |
| Definition | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Short | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Control | 0..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 404. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator | |
| Definition | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Short | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 406. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation | |
| Definition | 9.3.2.5 |
| Short | 9.3.2.5 |
| Control | 0..1 |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 408. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 410. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 412. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 414. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 416. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 418. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 420. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 422. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 424. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 426. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 428. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 430. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 432. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 434. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 436. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 438. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 440. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 442. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 444. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 446. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container | |
| Definition | 9.6.2.3 |
| Short | 9.6.2.3 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 448. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 450. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PackageItem-ContainerType | |
| Definition | The package item (container) type shall be specified to describe the physical type of the container of the medicine in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. A term and a term identifier shall be specified. (9.6.2.3.2) |
| Short | The package item (container) type shall be specified to describe the physical type of the container of the medicine in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. A term and a term identifier shall be specified. (9.6.2.3.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 452. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PackageItem-ContainerQuantity | |
| Definition | The quantity (or count number) of the package item shall be specified. Because the package item class recurses to describe containers within containers, the first (outermost) container shall always have a quantity of “1”. (9.6.2.3.3) |
| Short | The quantity (or count number) of the package item shall be specified. Because the package item class recurses to describe containers within containers, the first (outermost) container shall always have a quantity of “1”. (9.6.2.3.3) |
| Control | 1..1 |
| Type | Quantity |
| 454. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Material | |
| Definition | The material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology as applicable. A term and a term identifier shall be specified. (9.6.2.3.4) |
| Short | The material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology as applicable. A term and a term identifier shall be specified. (9.6.2.3.4) |
| Control | 1..* |
| Type | CodeableConcept |
| 456. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.AlternateMaterial | |
| Definition | The alternate material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 1 9844 and its resulting terminology as applicable. A term and a term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a blister sleeve). (9.6.2.3.5) |
| Short | The alternate material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 1 9844 and its resulting terminology as applicable. A term and a term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a blister sleeve). (9.6.2.3.5) |
| Control | 0..* |
| Type | CodeableConcept |
| 458. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier | |
| Definition | 9.6.2.4 |
| Short | 9.6.2.4 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 460. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 462. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier.CodeSystem | |
| Definition | The data carrier identification system itself shall be specified using an appropriate identification system. (9.6.2.4.2) |
| Short | The data carrier identification system itself shall be specified using an appropriate identification system. (9.6.2.4.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 464. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier.Value | |
| Definition | The individual value from the identification system that applies to the Packaged Medicinal Product shall be specified. (9.6.2.4.3) |
| Short | The individual value from the identification system that applies to the Packaged Medicinal Product shall be specified. (9.6.2.4.3) |
| Control | 1..1 |
| Type | CodeableConcept |
| 466. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device | |
| Definition | 9.6.2.12 |
| Short | 9.6.2.12 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 468. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 470. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceType | |
| Definition | The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2) |
| Short | The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 472. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceTradeName | |
| Definition | This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3) |
| Short | This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 474. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceQuantity | |
| Definition | The quantity of the device present in the pack shall be specified. (9.6.2.12.4) |
| Short | The quantity of the device present in the pack shall be specified. (9.6.2.12.4) |
| Control | 1..1 |
| Type | Quantity |
| 476. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceListingNumber | |
| Definition | This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5) |
| Short | This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 478. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceIdentifier | |
| Definition | A unique device identifier needs to be specified. (9.6.2.12.6) |
| Short | A unique device identifier needs to be specified. (9.6.2.12.6) |
| Control | 0..1 |
| Type | Identifier |
| 480. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.ModelNumber | |
| Definition | This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7) |
| Short | This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 482. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.SterilityIndicator | |
| Definition | Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8) |
| Short | Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8) |
| Control | 0..1 |
| Type | CodeableConcept |
| 484. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.SterilisationRequirementIndicator | |
| Definition | Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9) |
| Short | Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9) |
| Control | 0..1 |
| Type | CodeableConcept |
| 486. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceUsage | |
| Definition | The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10) |
| Short | The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10) |
| Control | 0..1 |
| Type | CodeableConcept |
| 488. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier | |
| Definition | 11.12 |
| Short | 11.12 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 490. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 492. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier.BatchNumber | |
| Definition | Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2) |
| Short | Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 494. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier.ExpirationDate | |
| Definition | Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3) |
| Short | Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3) |
| Control | 1..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 496. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial | |
| Definition | 9.6.2.13 |
| Short | 9.6.2.13 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 498. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 500. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.Substance | |
| Definition | The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2) |
| Short | The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 502. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.Alternate | |
| Definition | This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3) |
| Short | This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3) |
| Control | 0..1 |
| Type | Element(BL) |
| 504. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.AllergenicIndicator | |
| Definition | This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4) |
| Short | This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4) |
| Control | 0..1 |
| Type | Element(BL) |
| 506. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature | |
| Definition | 11.11 |
| Short | 11.11 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 508. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 510. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature.CodeSystem | |
| Definition | The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2) |
| Short | The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 512. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature.Value | |
| Definition | The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3) |
| Short | The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3) |
| Control | 1..1 |
| Type | CodeableConcept |
| 514. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation | |
| Definition | 9.5.2.2 |
| Short | 9.5.2.2 |
| Control | 0..1 |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 516. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 518. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 520. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 522. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 524. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 526. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 528. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 530. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 532. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 534. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 536. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 538. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 540. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 542. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 544. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 546. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 548. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 550. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 552. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 554. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation | |
| Definition | 9.5.2.3 |
| Short | 9.5.2.3 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 556. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 558. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType | |
| Definition | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Short | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 560. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber | |
| Definition | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Short | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Control | 0..1 |
| Type | Identifier |
| 562. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate | |
| Definition | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Short | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Control | 0..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 564. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator | |
| Definition | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Short | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 566. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation | |
| Definition | 9.3.2.5 |
| Short | 9.3.2.5 |
| Control | 0..1 |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 568. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 570. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 572. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 574. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 576. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 578. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 580. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 582. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 584. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 586. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 588. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 590. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 592. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 594. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 596. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 598. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 600. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 602. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 604. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 606. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics | |
| Definition | 9.6.2.22 |
| Short | 9.6.2.22 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 608. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 610. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics.CodeSystem | |
| Definition | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) |
| Short | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 612. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics.Value | |
| Definition | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) |
| Short | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) |
| Control | 1..1 |
| Type | CodeableConcept |
| 614. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics | |
| Definition | 11.13 |
| Short | 11.13 |
| Control | 0..1 |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 616. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 618. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Height | |
| Definition | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) |
| Short | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) |
| Control | 0..1 |
| Type | Quantity |
| 620. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Width | |
| Definition | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) |
| Short | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) |
| Control | 0..1 |
| Type | Quantity |
| 622. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Depth | |
| Definition | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) |
| Short | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) |
| Control | 0..1 |
| Type | Quantity |
| 624. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Weight | |
| Definition | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) |
| Short | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) |
| Control | 0..1 |
| Type | Quantity |
| 626. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.NominalVolume | |
| Definition | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) |
| Short | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) |
| Control | 0..1 |
| Type | Quantity |
| 628. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.ExternalDiameter | |
| Definition | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) |
| Short | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) |
| Control | 0..1 |
| Type | Quantity |
| 630. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Shape | |
| Definition | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) |
| Short | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 632. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Colour | |
| Definition | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) |
| Short | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 634. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Imprint | |
| Definition | Where applicable, the imprint can be specified as text. (9.6.2.21.10) |
| Short | Where applicable, the imprint can be specified as text. (9.6.2.21.10) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 636. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Image | |
| Definition | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) |
| Short | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) |
| Control | 0..* |
| Type | base64Binary |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 638. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Scoring | |
| Definition | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) |
| Short | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) |
| Control | 0..1 |
| Type | CodeableConcept |
| 640. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage | |
| Definition | 9.6.2.11 |
| Short | 9.6.2.11 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 642. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 644. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.ShelfLifeType | |
| Definition | This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2) |
| Short | This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 646. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.ShelfLifeTimePeriod | |
| Definition | The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3) |
| Short | The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3) |
| Control | 1..1 |
| Type | Quantity |
| 648. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.SpecialPrecautionsForStorage | |
| Definition | Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4) |
| Short | Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4) |
| Control | 0..* |
| Type | CodeableConcept |
| 650. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem | |
| Definition | 9.6.2.20 |
| Short | 9.6.2.20 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 652. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 654. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.ManufacturedDoseForm | |
| Definition | This describes the pharmaceutical dose form of the manufactured item, where applicable, before transformation into the pharmaceutical product. The manufactured dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. A Medicinal Product may have two package items, e.g. one with a manufactured dose form of powder for solution for injection and the other with a manufactured dose form of solvent for solution for injection. These are then to be transformed to a solution for injection before the medicine can be administered to a patient. Powder and solvent for solution for injection is the “combined pharmaceutical dose form”, which is an attribute of “Medicinal Product” and solution for injection is the “administrable dose form”, which is an attribute of “pharmaceutical product”. (9.6.2.20.2) |
| Short | This describes the pharmaceutical dose form of the manufactured item, where applicable, before transformation into the pharmaceutical product. The manufactured dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. A Medicinal Product may have two package items, e.g. one with a manufactured dose form of powder for solution for injection and the other with a manufactured dose form of solvent for solution for injection. These are then to be transformed to a solution for injection before the medicine can be administered to a patient. Powder and solvent for solution for injection is the “combined pharmaceutical dose form”, which is an attribute of “Medicinal Product” and solution for injection is the “administrable dose form”, which is an attribute of “pharmaceutical product”. (9.6.2.20.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 656. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.UnitOfPresentation | |
| Definition | This specifies the “real world” units in which the quantity of the manufactured item is described. The unit of presentation can be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. For items where their quantity is a measured quantity of weight or volume, the “unit of presentation” shall not be given since it is the same as the units of that quantity (that is ml, mg or %). For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.3) |
| Short | This specifies the “real world” units in which the quantity of the manufactured item is described. The unit of presentation can be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. For items where their quantity is a measured quantity of weight or volume, the “unit of presentation” shall not be given since it is the same as the units of that quantity (that is ml, mg or %). For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.3) |
| Control | 0..1 |
| Type | CodeableConcept |
| 658. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.ManufacturedItemQuantity | |
| Definition | The quantity (or count number) of the manufactured item shall be described. It shall be specified as a value and units, and the units shall be specified as a symbol and a symbol identifier as defined in ISO 11240 and the resulting terminology. For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.4) |
| Short | The quantity (or count number) of the manufactured item shall be described. It shall be specified as a value and units, and the units shall be specified as a symbol and a symbol identifier as defined in ISO 11240 and the resulting terminology. For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.4) |
| Control | 1..1 |
| Type | Quantity |
| 660. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient | |
| Definition | 11.2.9 |
| Short | 11.2.9 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 662. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 664. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.IngredientRole | |
| Definition | The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2) |
| Short | The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 666. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.AllergenicIndicator | |
| Definition | This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3) |
| Short | This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3) |
| Control | 0..1 |
| Type | Element(BL) |
| 668. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation | |
| Definition | 9.5.2.2 |
| Short | 9.5.2.2 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 670. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 672. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 674. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 676. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 678. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 680. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 682. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 684. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 686. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 688. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 690. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 692. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 694. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 696. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 698. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 700. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 702. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 704. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 706. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 708. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation | |
| Definition | 9.5.2.3 |
| Short | 9.5.2.3 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 710. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 712. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType | |
| Definition | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Short | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 714. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber | |
| Definition | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Short | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Control | 0..1 |
| Type | Identifier |
| 716. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate | |
| Definition | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Short | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Control | 0..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 718. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator | |
| Definition | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Short | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 720. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation | |
| Definition | 9.3.2.5 |
| Short | 9.3.2.5 |
| Control | 0..1 |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 722. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 724. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 726. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 728. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 730. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 732. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 734. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 736. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 738. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 740. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 742. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 744. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 746. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 748. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 750. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 752. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 754. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 756. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 758. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 760. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance | |
| Definition | 9.7.2.4 |
| Short | 9.7.2.4 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 762. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 764. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.SpecifiedSubstance | |
| Definition | When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2) |
| Short | When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 766. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.SpecifiedSubstanceGroup | |
| Definition | The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3) |
| Short | The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3) |
| Control | 1..1 |
| Type | CodeableConcept |
| 768. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.ConfidentialityIndicator | |
| Definition | The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4) |
| Short | The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4) |
| Control | 0..1 |
| Type | CodeableConcept |
| 770. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength | |
| Definition | 9.7.2.5 |
| Short | 9.7.2.5 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 772. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 774. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Strength-Presentation | |
| Definition | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) |
| Short | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) |
| Control | 1..1 |
| Type | Ratio |
| 776. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Strength-Concentration | |
| Definition | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) |
| Short | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) |
| Control | 0..1 |
| Type | Ratio |
| 778. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.MeasurementPoint | |
| Definition | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) |
| Short | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 780. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Country | |
| Definition | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) |
| Short | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) |
| Control | 0..* |
| Type | CodeableConcept |
| 782. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength | |
| Definition | 9.7.2.6 |
| Short | 9.7.2.6 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 784. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 786. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSubstance | |
| Definition | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) |
| Short | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) |
| Control | 0..1 |
| Type | CodeableConcept |
| 788. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance | |
| Definition | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) |
| Short | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) |
| Control | 0..1 |
| Type | CodeableConcept |
| 790. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrength | |
| Definition | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) |
| Short | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) |
| Control | 1..1 |
| Type | Ratio |
| 792. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint | |
| Definition | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) |
| Short | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 794. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthCountry | |
| Definition | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) |
| Short | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) |
| Control | 0..* |
| Type | CodeableConcept |
| 796. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance | |
| Definition | 9.7.2.3 |
| Short | 9.7.2.3 |
| Control | 0..1 |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 798. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 800. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Substance | |
| Definition | A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2) |
| Short | A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 802. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength | |
| Definition | 9.7.2.5 |
| Short | 9.7.2.5 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 804. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 806. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.Strength-Presentation | |
| Definition | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) |
| Short | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) |
| Control | 1..1 |
| Type | Ratio |
| 808. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.Strength-Concentration | |
| Definition | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) |
| Short | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) |
| Control | 0..1 |
| Type | Ratio |
| 810. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.MeasurementPoint | |
| Definition | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) |
| Short | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 812. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.Country | |
| Definition | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) |
| Short | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) |
| Control | 0..* |
| Type | CodeableConcept |
| 814. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength | |
| Definition | 9.7.2.6 |
| Short | 9.7.2.6 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 816. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 818. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSubstance | |
| Definition | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) |
| Short | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) |
| Control | 0..1 |
| Type | CodeableConcept |
| 820. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance | |
| Definition | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) |
| Short | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) |
| Control | 0..1 |
| Type | CodeableConcept |
| 822. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrength | |
| Definition | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) |
| Short | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) |
| Control | 1..1 |
| Type | Ratio |
| 824. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint | |
| Definition | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) |
| Short | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 826. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthCountry | |
| Definition | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) |
| Short | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) |
| Control | 0..* |
| Type | CodeableConcept |
| 828. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation | |
| Definition | 9.5.2.2 |
| Short | 9.5.2.2 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 830. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 832. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 834. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 836. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 838. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 840. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 842. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 844. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 846. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 848. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 850. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 852. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 854. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 856. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 858. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 860. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 862. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 864. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 866. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 868. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation | |
| Definition | 9.5.2.3 |
| Short | 9.5.2.3 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 870. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 872. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType | |
| Definition | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Short | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 874. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber | |
| Definition | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Short | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Control | 0..1 |
| Type | Identifier |
| 876. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate | |
| Definition | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Short | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Control | 0..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 878. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator | |
| Definition | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Short | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 880. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation | |
| Definition | 9.3.2.5 |
| Short | 9.3.2.5 |
| Control | 0..1 |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 882. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 884. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 886. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 888. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 890. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 892. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 894. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 896. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 898. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 900. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 902. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 904. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 906. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 908. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 910. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 912. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 914. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 916. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 918. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 920. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics | |
| Definition | 9.6.2.22 |
| Short | 9.6.2.22 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 922. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 924. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics.CodeSystem | |
| Definition | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) |
| Short | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 926. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics.Value | |
| Definition | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) |
| Short | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) |
| Control | 1..1 |
| Type | CodeableConcept |
| 928. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics | |
| Definition | 11.13 |
| Short | 11.13 |
| Control | 0..1 |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 930. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 932. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Height | |
| Definition | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) |
| Short | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) |
| Control | 0..1 |
| Type | Quantity |
| 934. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Width | |
| Definition | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) |
| Short | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) |
| Control | 0..1 |
| Type | Quantity |
| 936. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Depth | |
| Definition | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) |
| Short | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) |
| Control | 0..1 |
| Type | Quantity |
| 938. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Weight | |
| Definition | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) |
| Short | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) |
| Control | 0..1 |
| Type | Quantity |
| 940. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.NominalVolume | |
| Definition | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) |
| Short | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) |
| Control | 0..1 |
| Type | Quantity |
| 942. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.ExternalDiameter | |
| Definition | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) |
| Short | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) |
| Control | 0..1 |
| Type | Quantity |
| 944. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Shape | |
| Definition | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) |
| Short | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 946. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Colour | |
| Definition | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) |
| Short | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 948. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Imprint | |
| Definition | Where applicable, the imprint can be specified as text. (9.6.2.21.10) |
| Short | Where applicable, the imprint can be specified as text. (9.6.2.21.10) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 950. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Image | |
| Definition | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) |
| Short | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) |
| Control | 0..* |
| Type | base64Binary |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 952. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Scoring | |
| Definition | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) |
| Short | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) |
| Control | 0..1 |
| Type | CodeableConcept |
| 954. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation | |
| Definition | 9.5.2.2 |
| Short | 9.5.2.2 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 956. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 958. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 960. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 962. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 964. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 966. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 968. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 970. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 972. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 974. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 976. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 978. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 980. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 982. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 984. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 986. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 988. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 990. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 992. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 994. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation | |
| Definition | 9.5.2.3 |
| Short | 9.5.2.3 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 996. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 998. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType | |
| Definition | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Short | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1000. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber | |
| Definition | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Short | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Control | 0..1 |
| Type | Identifier |
| 1002. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate | |
| Definition | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Short | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Control | 0..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1004. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator | |
| Definition | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Short | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1006. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation | |
| Definition | 9.3.2.5 |
| Short | 9.3.2.5 |
| Control | 0..1 |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1008. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1010. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 1012. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1014. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 1016. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1018. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1020. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1022. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1024. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 1026. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 1028. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1030. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1032. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1034. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1036. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1038. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 1040. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1042. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 1044. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1046. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics | |
| Definition | 9.6.2.22 |
| Short | 9.6.2.22 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1048. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1050. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics.CodeSystem | |
| Definition | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) |
| Short | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1052. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics.Value | |
| Definition | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) |
| Short | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1054. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component | |
| Definition | 9.6.2.9 |
| Short | 9.6.2.9 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1056. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1058. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.ComponentType | |
| Definition | The type of component whose material is being described may be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.9.2) |
| Short | The type of component whose material is being described may be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.9.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1060. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.ComponentMaterial | |
| Definition | The material(s) of the component can be specified. Materials may be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. (9.6.2.9.3) |
| Short | The material(s) of the component can be specified. Materials may be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. (9.6.2.9.3) |
| Control | 0..* |
| Type | CodeableConcept |
| 1062. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.ComponentAlternateMaterial | |
| Definition | Alternative materials for the component can be specified. Materials shall be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of rubber for a stopper). (9.6.2.9.4) |
| Short | Alternative materials for the component can be specified. Materials shall be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of rubber for a stopper). (9.6.2.9.4) |
| Control | 0..* |
| Type | CodeableConcept |
| 1064. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation | |
| Definition | 9.5.2.2 |
| Short | 9.5.2.2 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1066. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1068. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 1070. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1072. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 1074. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1076. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1078. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1080. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1082. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 1084. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 1086. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1088. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1090. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1092. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1094. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1096. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 1098. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1100. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 1102. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1104. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation | |
| Definition | 9.5.2.3 |
| Short | 9.5.2.3 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1106. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1108. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType | |
| Definition | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Short | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1110. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber | |
| Definition | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Short | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Control | 0..1 |
| Type | Identifier |
| 1112. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate | |
| Definition | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Short | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Control | 0..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1114. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator | |
| Definition | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Short | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1116. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation | |
| Definition | 9.3.2.5 |
| Short | 9.3.2.5 |
| Control | 0..1 |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1118. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1120. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 1122. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1124. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 1126. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1128. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1130. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1132. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1134. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 1136. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 1138. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1140. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1142. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1144. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1146. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1148. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 1150. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1152. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 1154. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1156. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics | |
| Definition | 11.13 |
| Short | 11.13 |
| Control | 0..1 |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1158. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1160. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Height | |
| Definition | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) |
| Short | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) |
| Control | 0..1 |
| Type | Quantity |
| 1162. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Width | |
| Definition | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) |
| Short | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) |
| Control | 0..1 |
| Type | Quantity |
| 1164. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Depth | |
| Definition | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) |
| Short | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) |
| Control | 0..1 |
| Type | Quantity |
| 1166. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Weight | |
| Definition | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) |
| Short | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) |
| Control | 0..1 |
| Type | Quantity |
| 1168. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.NominalVolume | |
| Definition | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) |
| Short | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) |
| Control | 0..1 |
| Type | Quantity |
| 1170. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.ExternalDiameter | |
| Definition | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) |
| Short | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) |
| Control | 0..1 |
| Type | Quantity |
| 1172. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Shape | |
| Definition | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) |
| Short | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1174. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Colour | |
| Definition | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) |
| Short | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1176. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Imprint | |
| Definition | Where applicable, the imprint can be specified as text. (9.6.2.21.10) |
| Short | Where applicable, the imprint can be specified as text. (9.6.2.21.10) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1178. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Image | |
| Definition | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) |
| Short | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) |
| Control | 0..* |
| Type | base64Binary |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1180. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Scoring | |
| Definition | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) |
| Short | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1182. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics | |
| Definition | 11.13 |
| Short | 11.13 |
| Control | 0..1 |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1184. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1186. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Height | |
| Definition | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) |
| Short | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) |
| Control | 0..1 |
| Type | Quantity |
| 1188. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Width | |
| Definition | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) |
| Short | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) |
| Control | 0..1 |
| Type | Quantity |
| 1190. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Depth | |
| Definition | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) |
| Short | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) |
| Control | 0..1 |
| Type | Quantity |
| 1192. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Weight | |
| Definition | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) |
| Short | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) |
| Control | 0..1 |
| Type | Quantity |
| 1194. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.NominalVolume | |
| Definition | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) |
| Short | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) |
| Control | 0..1 |
| Type | Quantity |
| 1196. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.ExternalDiameter | |
| Definition | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) |
| Short | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) |
| Control | 0..1 |
| Type | Quantity |
| 1198. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Shape | |
| Definition | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) |
| Short | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1200. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Colour | |
| Definition | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) |
| Short | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1202. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Imprint | |
| Definition | Where applicable, the imprint can be specified as text. (9.6.2.21.10) |
| Short | Where applicable, the imprint can be specified as text. (9.6.2.21.10) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1204. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Image | |
| Definition | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) |
| Short | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) |
| Control | 0..* |
| Type | base64Binary |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1206. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Scoring | |
| Definition | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) |
| Short | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1208. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage | |
| Definition | 9.6.2.11 |
| Short | 9.6.2.11 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1210. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1212. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.ShelfLifeType | |
| Definition | This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2) |
| Short | This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1214. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.ShelfLifeTimePeriod | |
| Definition | The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3) |
| Short | The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3) |
| Control | 1..1 |
| Type | Quantity |
| 1216. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.SpecialPrecautionsForStorage | |
| Definition | Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4) |
| Short | Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4) |
| Control | 0..* |
| Type | CodeableConcept |
| 1218. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation | |
| Definition | 9.5.2.2 |
| Short | 9.5.2.2 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1220. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1222. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 1224. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1226. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 1228. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1230. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1232. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1234. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1236. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 1238. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 1240. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1242. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1244. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1246. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1248. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1250. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 1252. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1254. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 1256. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1258. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation | |
| Definition | 9.5.2.3 |
| Short | 9.5.2.3 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1260. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1262. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType | |
| Definition | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Short | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1264. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber | |
| Definition | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Short | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Control | 0..1 |
| Type | Identifier |
| 1266. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate | |
| Definition | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Short | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Control | 0..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1268. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator | |
| Definition | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Short | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1270. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation | |
| Definition | 9.3.2.5 |
| Short | 9.3.2.5 |
| Control | 0..1 |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1272. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1274. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 1276. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1278. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 1280. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1282. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1284. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1286. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1288. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 1290. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 1292. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1294. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1296. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1298. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1300. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1302. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 1304. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1306. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 1308. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1310. InvestigationalMedicinalProduct.OrphanDesignation | |
| Definition | 9.2.2.3 |
| Short | 9.2.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1312. InvestigationalMedicinalProduct.OrphanDesignation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1314. InvestigationalMedicinalProduct.OrphanDesignation.OrphanIndicationType | |
| Definition | This attribute is for the type of intended use of the Medicinal Product, for instance disease prevention, treatment or diagnostic. (9.2.2.3.2) |
| Short | This attribute is for the type of intended use of the Medicinal Product, for instance disease prevention, treatment or diagnostic. (9.2.2.3.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1316. InvestigationalMedicinalProduct.OrphanDesignation.OrphanProcedureNumber | |
| Definition | This attribute is the procedure number for the orphan designation authorisation application. (9.2.2.3.3) |
| Short | This attribute is the procedure number for the orphan designation authorisation application. (9.2.2.3.3) |
| Control | 0..1 |
| Type | Identifier |
| 1318. InvestigationalMedicinalProduct.OrphanDesignation.OrphanDesignationAuthorisationStatus | |
| Definition | This attribute is for describing the status of the orphan designation authorisation, for instance granted, pending, expired or withdrawn. (9.2.2.3.4) |
| Short | This attribute is for describing the status of the orphan designation authorisation, for instance granted, pending, expired or withdrawn. (9.2.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1320. InvestigationalMedicinalProduct.OrphanDesignation.OrphanDesignationAuthorisationDate | |
| Definition | This attribute is for the date in which the orphan designation status was granted. (9.2.2.3.5) |
| Short | This attribute is for the date in which the orphan designation status was granted. (9.2.2.3.5) |
| Control | 0..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1322. InvestigationalMedicinalProduct.OrphanDesignation.OrphanDesignationNumber | |
| Definition | This field is to indicate the orphan designation decision number. (9.2.2.3.6) |
| Short | This field is to indicate the orphan designation decision number. (9.2.2.3.6) |
| Control | 0..1 |
| Type | Identifier |
| 1324. InvestigationalMedicinalProduct.PharmaceuticalProduct | |
| Definition | 11.7.2 |
| Short | 11.7.2 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1326. InvestigationalMedicinalProduct.PharmaceuticalProduct.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1328. InvestigationalMedicinalProduct.PharmaceuticalProduct.AdministrableDoseForm | |
| Definition | This shall describe the administrable dose form in accordance with the regulated product information. This is after it has undergone any necessary reconstitution, where applicable. The administrable dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and the resulting terminology. The term and the term identifier shall be specified. In certain instances, the administrable dose form differs from the manufactured dose form when a transformation of the manufactured dose form has been carried out. The manufactured dose forms of two manufactured items are described as “powder for solution for injection” and “solvent for solution for injection” which after transformation correspond to the administrable dose form “solution for injection”. (9.8.2.2.2) |
| Short | This shall describe the administrable dose form in accordance with the regulated product information. This is after it has undergone any necessary reconstitution, where applicable. The administrable dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and the resulting terminology. The term and the term identifier shall be specified. In certain instances, the administrable dose form differs from the manufactured dose form when a transformation of the manufactured dose form has been carried out. The manufactured dose forms of two manufactured items are described as “powder for solution for injection” and “solvent for solution for injection” which after transformation correspond to the administrable dose form “solution for injection”. (9.8.2.2.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1330. InvestigationalMedicinalProduct.PharmaceuticalProduct.UnitOfPresentation | |
| Definition | The unit of presentation is a qualitative term describing the discrete unit in which a pharmaceutical product is presented to describe strength or quantity in cases where a quantitative unit of measurement is not appropriate. It is a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. For pharmaceutical products whose strength is measured as a quantity of weight or volume, the “unit of presentation” can be specified as the immediate (lowest level) container. For solid dose forms and other items whose strength is described on the basis of the amount in the unit of presentation, and which are counted in integer quantities, the unit for quantity shall be “1 unit” and the unit of presentation shall be the item that is counted, specified as a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. (9.8.2.2.3) |
| Short | The unit of presentation is a qualitative term describing the discrete unit in which a pharmaceutical product is presented to describe strength or quantity in cases where a quantitative unit of measurement is not appropriate. It is a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. For pharmaceutical products whose strength is measured as a quantity of weight or volume, the “unit of presentation” can be specified as the immediate (lowest level) container. For solid dose forms and other items whose strength is described on the basis of the amount in the unit of presentation, and which are counted in integer quantities, the unit for quantity shall be “1 unit” and the unit of presentation shall be the item that is counted, specified as a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. (9.8.2.2.3) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1332. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device | |
| Definition | 9.6.2.12 |
| Short | 9.6.2.12 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1334. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1336. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceType | |
| Definition | The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2) |
| Short | The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1338. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceTradeName | |
| Definition | This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3) |
| Short | This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1340. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceQuantity | |
| Definition | The quantity of the device present in the pack shall be specified. (9.6.2.12.4) |
| Short | The quantity of the device present in the pack shall be specified. (9.6.2.12.4) |
| Control | 1..1 |
| Type | Quantity |
| 1342. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceListingNumber | |
| Definition | This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5) |
| Short | This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1344. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceIdentifier | |
| Definition | A unique device identifier needs to be specified. (9.6.2.12.6) |
| Short | A unique device identifier needs to be specified. (9.6.2.12.6) |
| Control | 0..1 |
| Type | Identifier |
| 1346. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.ModelNumber | |
| Definition | This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7) |
| Short | This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1348. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.SterilityIndicator | |
| Definition | Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8) |
| Short | Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1350. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.SterilisationRequirementIndicator | |
| Definition | Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9) |
| Short | Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1352. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceUsage | |
| Definition | The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10) |
| Short | The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1354. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier | |
| Definition | 11.12 |
| Short | 11.12 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1356. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1358. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.BatchNumber | |
| Definition | Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2) |
| Short | Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1360. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.ExpirationDate | |
| Definition | Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3) |
| Short | Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3) |
| Control | 1..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1362. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial | |
| Definition | 9.6.2.13 |
| Short | 9.6.2.13 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1364. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1366. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.Substance | |
| Definition | The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2) |
| Short | The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1368. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.Alternate | |
| Definition | This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3) |
| Short | This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3) |
| Control | 0..1 |
| Type | Element(BL) |
| 1370. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.AllergenicIndicator | |
| Definition | This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4) |
| Short | This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4) |
| Control | 0..1 |
| Type | Element(BL) |
| 1372. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature | |
| Definition | 11.11 |
| Short | 11.11 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1374. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1376. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.CodeSystem | |
| Definition | The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2) |
| Short | The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1378. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.Value | |
| Definition | The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3) |
| Short | The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1380. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation | |
| Definition | 9.5.2.2 |
| Short | 9.5.2.2 |
| Control | 0..1 |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1382. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1384. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 1386. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1388. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 1390. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1392. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1394. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1396. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1398. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 1400. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 1402. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1404. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1406. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1408. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1410. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1412. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 1414. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1416. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 1418. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1420. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation | |
| Definition | 9.5.2.3 |
| Short | 9.5.2.3 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1422. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1424. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType | |
| Definition | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Short | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1426. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber | |
| Definition | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Short | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Control | 0..1 |
| Type | Identifier |
| 1428. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate | |
| Definition | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Short | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Control | 0..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1430. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator | |
| Definition | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Short | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1432. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation | |
| Definition | 9.3.2.5 |
| Short | 9.3.2.5 |
| Control | 0..1 |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1434. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1436. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 1438. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1440. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 1442. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1444. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1446. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1448. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1450. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 1452. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 1454. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1456. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1458. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1460. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1462. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1464. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 1466. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1468. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 1470. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1472. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics | |
| Definition | 9.6.2.22 |
| Short | 9.6.2.22 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1474. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1476. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.CodeSystem | |
| Definition | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) |
| Short | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1478. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.Value | |
| Definition | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) |
| Short | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1480. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics | |
| Definition | 11.13 |
| Short | 11.13 |
| Control | 0..1 |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1482. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1484. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Height | |
| Definition | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) |
| Short | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) |
| Control | 0..1 |
| Type | Quantity |
| 1486. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Width | |
| Definition | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) |
| Short | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) |
| Control | 0..1 |
| Type | Quantity |
| 1488. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Depth | |
| Definition | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) |
| Short | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) |
| Control | 0..1 |
| Type | Quantity |
| 1490. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Weight | |
| Definition | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) |
| Short | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) |
| Control | 0..1 |
| Type | Quantity |
| 1492. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.NominalVolume | |
| Definition | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) |
| Short | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) |
| Control | 0..1 |
| Type | Quantity |
| 1494. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.ExternalDiameter | |
| Definition | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) |
| Short | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) |
| Control | 0..1 |
| Type | Quantity |
| 1496. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Shape | |
| Definition | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) |
| Short | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1498. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Colour | |
| Definition | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) |
| Short | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1500. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Imprint | |
| Definition | Where applicable, the imprint can be specified as text. (9.6.2.21.10) |
| Short | Where applicable, the imprint can be specified as text. (9.6.2.21.10) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1502. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Image | |
| Definition | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) |
| Short | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) |
| Control | 0..* |
| Type | base64Binary |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1504. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Scoring | |
| Definition | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) |
| Short | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1506. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage | |
| Definition | 9.6.2.11 |
| Short | 9.6.2.11 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1508. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1510. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.ShelfLifeType | |
| Definition | This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2) |
| Short | This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1512. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.ShelfLifeTimePeriod | |
| Definition | The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3) |
| Short | The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3) |
| Control | 1..1 |
| Type | Quantity |
| 1514. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.SpecialPrecautionsForStorage | |
| Definition | Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4) |
| Short | Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4) |
| Control | 0..* |
| Type | CodeableConcept |
| 1516. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration | |
| Definition | 11.7.3 |
| Short | 11.7.3 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1518. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1520. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration.RouteOfAdministration | |
| Definition | (11.7.3.0) |
| Short | (11.7.3.0) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1522. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration.FirstDoseInHumans | |
| Definition | The first dose (dose quantity) administered in humans can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and symbol identifier shall be used. (11.7.3.2) |
| Short | The first dose (dose quantity) administered in humans can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and symbol identifier shall be used. (11.7.3.2) |
| Control | 0..1 |
| Type | Quantity |
| 1524. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration.MaximumSingleDose | |
| Definition | The maximum single dose (maximum single dose quantity) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.3) |
| Short | The maximum single dose (maximum single dose quantity) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.3) |
| Control | 0..1 |
| Type | Quantity |
| 1526. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration.MaximumDosePerDay | |
| Definition | The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.4) |
| Short | The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.4) |
| Control | 0..1 |
| Type | Quantity |
| 1528. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration.MaximumDosePerTreatmentPeriod | |
| Definition | The maximum dose per treatment period (maximum total dose quantity to be administered in the treatment period) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.5) |
| Short | The maximum dose per treatment period (maximum total dose quantity to be administered in the treatment period) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.5) |
| Control | 0..1 |
| Type | Ratio |
| 1530. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration.MaximumTreatmentPeriod | |
| Definition | The maximum treatment period during which the Investigational Medicinal Product can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of time measurement. The unit of time measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.6) |
| Short | The maximum treatment period during which the Investigational Medicinal Product can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of time measurement. The unit of time measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.6) |
| Control | 0..1 |
| Type | Quantity |
| 1532. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient | |
| Definition | 11.2.9 |
| Short | 11.2.9 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1534. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1536. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.IngredientRole | |
| Definition | The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2) |
| Short | The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1538. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.AllergenicIndicator | |
| Definition | This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3) |
| Short | This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3) |
| Control | 0..1 |
| Type | Element(BL) |
| 1540. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation | |
| Definition | 9.5.2.2 |
| Short | 9.5.2.2 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1542. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1544. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 1546. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1548. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 1550. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1552. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1554. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1556. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1558. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 1560. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 1562. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1564. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1566. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1568. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1570. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1572. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 1574. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1576. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 1578. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1580. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation | |
| Definition | 9.5.2.3 |
| Short | 9.5.2.3 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1582. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1584. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType | |
| Definition | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Short | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1586. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber | |
| Definition | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Short | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Control | 0..1 |
| Type | Identifier |
| 1588. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate | |
| Definition | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Short | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Control | 0..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1590. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator | |
| Definition | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Short | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1592. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation | |
| Definition | 9.3.2.5 |
| Short | 9.3.2.5 |
| Control | 0..1 |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1594. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1596. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 1598. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1600. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 1602. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1604. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1606. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1608. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1610. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 1612. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 1614. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1616. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1618. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1620. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1622. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1624. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 1626. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1628. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 1630. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1632. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance | |
| Definition | 9.7.2.4 |
| Short | 9.7.2.4 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1634. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1636. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.SpecifiedSubstance | |
| Definition | When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2) |
| Short | When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1638. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.SpecifiedSubstanceGroup | |
| Definition | The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3) |
| Short | The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1640. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.ConfidentialityIndicator | |
| Definition | The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4) |
| Short | The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1642. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength | |
| Definition | 9.7.2.5 |
| Short | 9.7.2.5 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1644. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1646. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Strength-Presentation | |
| Definition | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) |
| Short | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) |
| Control | 1..1 |
| Type | Ratio |
| 1648. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Strength-Concentration | |
| Definition | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) |
| Short | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) |
| Control | 0..1 |
| Type | Ratio |
| 1650. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.MeasurementPoint | |
| Definition | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) |
| Short | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1652. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Country | |
| Definition | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) |
| Short | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) |
| Control | 0..* |
| Type | CodeableConcept |
| 1654. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength | |
| Definition | 9.7.2.6 |
| Short | 9.7.2.6 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1656. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1658. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSubstance | |
| Definition | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) |
| Short | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1660. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance | |
| Definition | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) |
| Short | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1662. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrength | |
| Definition | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) |
| Short | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) |
| Control | 1..1 |
| Type | Ratio |
| 1664. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint | |
| Definition | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) |
| Short | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1666. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthCountry | |
| Definition | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) |
| Short | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) |
| Control | 0..* |
| Type | CodeableConcept |
| 1668. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance | |
| Definition | 9.7.2.3 |
| Short | 9.7.2.3 |
| Control | 0..1 |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1670. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1672. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Substance | |
| Definition | A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2) |
| Short | A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1674. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength | |
| Definition | 9.7.2.5 |
| Short | 9.7.2.5 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1676. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1678. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Strength-Presentation | |
| Definition | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) |
| Short | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) |
| Control | 1..1 |
| Type | Ratio |
| 1680. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Strength-Concentration | |
| Definition | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) |
| Short | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) |
| Control | 0..1 |
| Type | Ratio |
| 1682. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.MeasurementPoint | |
| Definition | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) |
| Short | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1684. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Country | |
| Definition | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) |
| Short | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) |
| Control | 0..* |
| Type | CodeableConcept |
| 1686. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength | |
| Definition | 9.7.2.6 |
| Short | 9.7.2.6 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1688. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1690. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSubstance | |
| Definition | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) |
| Short | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1692. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance | |
| Definition | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) |
| Short | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1694. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrength | |
| Definition | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) |
| Short | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) |
| Control | 1..1 |
| Type | Ratio |
| 1696. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint | |
| Definition | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) |
| Short | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1698. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthCountry | |
| Definition | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) |
| Short | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) |
| Control | 0..* |
| Type | CodeableConcept |
| 1700. InvestigationalMedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics | |
| Definition | 9.8.2.4 |
| Short | 9.8.2.4 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1702. InvestigationalMedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1704. InvestigationalMedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.CodeSystem | |
| Definition | The code system being used to describe the type of characteristic shall be specified using an appropriate identification system. (9.8.2.4.2) |
| Short | The code system being used to describe the type of characteristic shall be specified using an appropriate identification system. (9.8.2.4.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1706. InvestigationalMedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.Value | |
| Definition | The individual value from the code system that describes the actual characteristic shall be specified using a controlled term and a controlled term identifier. (9.8.2.4.3) |
| Short | The individual value from the code system that describes the actual characteristic shall be specified using a controlled term and a controlled term identifier. (9.8.2.4.3) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1708. InvestigationalMedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.Status | |
| Definition | The status of the pharmaceutical product characteristic should be listed here, e.g. assigned, not assigned or pending. (9.8.2.4.4) |
| Short | The status of the pharmaceutical product characteristic should be listed here, e.g. assigned, not assigned or pending. (9.8.2.4.4) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1710. InvestigationalMedicinalProduct.PharmaceuticalProduct.PhPIDSet | |
| Definition | 9.8.2.6 |
| Short | 9.8.2.6 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1712. InvestigationalMedicinalProduct.PharmaceuticalProduct.PhPIDSet.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1714. InvestigationalMedicinalProduct.PharmaceuticalProduct.PhPIDSet.PhPIDIdentifierSets | |
| Definition | This class shall carry the relevant identifiers as defined by ISO 11616 and ISO / TS 20451 . This provides a uniform representation of the pharmaceutical product using the substance(s)/specified substance(s), their (reference) strength(s), the administrable dose form and, where applicable, the integral device. (9.8.2.6.0) |
| Short | This class shall carry the relevant identifiers as defined by ISO 11616 and ISO / TS 20451 . This provides a uniform representation of the pharmaceutical product using the substance(s)/specified substance(s), their (reference) strength(s), the administrable dose form and, where applicable, the integral device. (9.8.2.6.0) |
| Control | 1..1 |
| Type | Identifier |
| 1716. InvestigationalMedicinalProduct.ProductClassification | |
| Definition | 11.3.2.7 |
| Short | 11.3.2.7 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1718. InvestigationalMedicinalProduct.ProductClassification.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1720. InvestigationalMedicinalProduct.ProductClassification.CodeSystem | |
| Definition | The Medicinal Product can be classified according to various classification systems, which may be regional, jurisdictional or international. The various classifications of the product can be specified in this subclause. The classification system shall be specified using an appropriate identification system; the controlled term and the controlled term identifier shall be specified. (9.2.2.4.2) |
| Short | The Medicinal Product can be classified according to various classification systems, which may be regional, jurisdictional or international. The various classifications of the product can be specified in this subclause. The classification system shall be specified using an appropriate identification system; the controlled term and the controlled term identifier shall be specified. (9.2.2.4.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1722. InvestigationalMedicinalProduct.ProductClassification.Value | |
| Definition | The individual value from the classification system that applies to the Medicinal Product shall be specified using a controlled term and a controlled term identifier. (9.2.2.4.3) |
| Short | The individual value from the classification system that applies to the Medicinal Product shall be specified using a controlled term and a controlled term identifier. (9.2.2.4.3) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1724. InvestigationalMedicinalProduct.ProductCross-Reference | |
| Definition | 11.3.2.4 |
| Short | 11.3.2.4 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1726. InvestigationalMedicinalProduct.ProductCross-Reference.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1728. InvestigationalMedicinalProduct.ProductCross-Reference.I-MPIDCross-Reference | |
| Definition | This is an attribute used to reference other IMPID(s) or MPID(s) related to the medicinal. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.2) |
| Short | This is an attribute used to reference other IMPID(s) or MPID(s) related to the medicinal. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.2) |
| Control | 1..1 |
| Type | Identifier |
| 1730. InvestigationalMedicinalProduct.ProductCross-Reference.ReferencedProductType | |
| Definition | This attribute is to identify which kind of Medicinal Product is cross-referenced. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.3) |
| Short | This attribute is to identify which kind of Medicinal Product is cross-referenced. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.3) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1732. InvestigationalMedicinalProduct.TherapeuticIndication | |
| Definition | 9.9.2.2 |
| Short | 9.9.2.2 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1734. InvestigationalMedicinalProduct.TherapeuticIndication.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1736. InvestigationalMedicinalProduct.TherapeuticIndication.IndicationText | |
| Definition | The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2) |
| Short | The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1738. InvestigationalMedicinalProduct.TherapeuticIndication.IndicationAsDisease-Symptom-Procedure | |
| Definition | The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3) |
| Short | The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1740. InvestigationalMedicinalProduct.TherapeuticIndication.DiseaseStatus | |
| Definition | The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4) |
| Short | The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1742. InvestigationalMedicinalProduct.TherapeuticIndication.Comorbidity | |
| Definition | If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5) |
| Short | If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5) |
| Control | 0..* |
| Type | CodeableConcept |
| 1744. InvestigationalMedicinalProduct.TherapeuticIndication.IntendedEffect | |
| Definition | The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6) |
| Short | The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1746. InvestigationalMedicinalProduct.TherapeuticIndication.Timing-Duration | |
| Definition | If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7) |
| Short | If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7) |
| Control | 0..1 |
| Type | Quantity |
| 1748. InvestigationalMedicinalProduct.TherapeuticIndication.OtherTherapySpecifics | |
| Definition | 9.9.2.6 |
| Short | 9.9.2.6 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1750. InvestigationalMedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1752. InvestigationalMedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.TherapyRelationshipType | |
| Definition | The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2) |
| Short | The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1754. InvestigationalMedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.Medication | |
| Definition | Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3) |
| Short | Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1756. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics | |
| Definition | 9.9.2.5 |
| Short | 9.9.2.5 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1758. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1760. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics.Age | |
| Definition | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) |
| Short | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1762. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics.AgeRangeLow | |
| Definition | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) |
| Short | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) |
| Control | 0..1 |
| Type | Quantity |
| 1764. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics.AgeRangeHigh | |
| Definition | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) |
| Short | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) |
| Control | 0..1 |
| Type | Quantity |
| 1766. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics.Gender | |
| Definition | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) |
| Short | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1768. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics.Race | |
| Definition | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) |
| Short | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1770. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics.PhysiologicalCondition | |
| Definition | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) |
| Short | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1772. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects | |
| Definition | 9.9.2.4 |
| Short | 9.9.2.4 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1774. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1776. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.UndesirableEffectText | |
| Definition | The text of the undesirable effect shall be given. (9.9.2.4.2) |
| Short | The text of the undesirable effect shall be given. (9.9.2.4.2) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1778. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.UndesirableEffectAsSymptom-Condition-Effect | |
| Definition | The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3) |
| Short | The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1780. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.Symptom-Condition-EffectClassification | |
| Definition | The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4) |
| Short | The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1782. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.FrequencyOfOccurrence | |
| Definition | The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5) |
| Short | The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1784. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics | |
| Definition | 9.9.2.5 |
| Short | 9.9.2.5 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1786. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1788. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Age | |
| Definition | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) |
| Short | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1790. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeLow | |
| Definition | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) |
| Short | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) |
| Control | 0..1 |
| Type | Quantity |
| 1792. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeHigh | |
| Definition | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) |
| Short | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) |
| Control | 0..1 |
| Type | Quantity |
| 1794. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Gender | |
| Definition | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) |
| Short | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1796. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Race | |
| Definition | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) |
| Short | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1798. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.PhysiologicalCondition | |
| Definition | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) |
| Short | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1800. InvestigationalMedicinalProduct.UndesirableEffects | |
| Definition | 9.9.2.4 |
| Short | 9.9.2.4 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1802. InvestigationalMedicinalProduct.UndesirableEffects.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1804. InvestigationalMedicinalProduct.UndesirableEffects.UndesirableEffectText | |
| Definition | The text of the undesirable effect shall be given. (9.9.2.4.2) |
| Short | The text of the undesirable effect shall be given. (9.9.2.4.2) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1806. InvestigationalMedicinalProduct.UndesirableEffects.UndesirableEffectAsSymptom-Condition-Effect | |
| Definition | The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3) |
| Short | The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1808. InvestigationalMedicinalProduct.UndesirableEffects.Symptom-Condition-EffectClassification | |
| Definition | The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4) |
| Short | The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1810. InvestigationalMedicinalProduct.UndesirableEffects.FrequencyOfOccurrence | |
| Definition | The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5) |
| Short | The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1812. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics | |
| Definition | 9.9.2.5 |
| Short | 9.9.2.5 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1814. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 1816. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics.Age | |
| Definition | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) |
| Short | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1818. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics.AgeRangeLow | |
| Definition | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) |
| Short | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) |
| Control | 0..1 |
| Type | Quantity |
| 1820. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics.AgeRangeHigh | |
| Definition | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) |
| Short | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) |
| Control | 0..1 |
| Type | Quantity |
| 1822. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics.Gender | |
| Definition | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) |
| Short | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1824. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics.Race | |
| Definition | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) |
| Short | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1826. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics.PhysiologicalCondition | |
| Definition | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) |
| Short | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) |
| Control | 0..1 |
| Type | CodeableConcept |
Guidance on how to interpret the contents of this table can be found here
| 0. InvestigationalMedicinalProduct | |
| Definition | ISO 11615 Investigational Medicinal Product |
| Control | 0..* |
| Is Modifier | false |
| Logical Model | Instances of this logical model are not marked to be the target of a Reference |
| 2. InvestigationalMedicinalProduct.IMPID | |
| Definition | The identifier for the Investigational Medicinal Product shall be always specified as text. (11.3.2.2.2) |
| Short | The identifier for the Investigational Medicinal Product shall be always specified as text. (11.3.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 4. InvestigationalMedicinalProduct.CombinedPharmaceuticalDoseForm | |
| Definition | The combined pharmaceutical dose form shall be specified, where applicable, as described in 9.2.2.2.3 . (11.3.2.2.3) |
| Short | The combined pharmaceutical dose form shall be specified, where applicable, as described in 9.2.2.2.3 . (11.3.2.2.3) |
| Control | 0..1 |
| Type | CodeableConcept |
| 6. InvestigationalMedicinalProduct.SponsorProductCode | |
| Definition | The product code (identifier) for the Investigational Medicinal Product as designated by the sponsor can be specified in text. Either this code or the regulator product code (see 1 1.3.2.2.5 ) shall be specified. (11.3.2.2.4) |
| Short | The product code (identifier) for the Investigational Medicinal Product as designated by the sponsor can be specified in text. Either this code or the regulator product code (see 1 1.3.2.2.5 ) shall be specified. (11.3.2.2.4) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 8. InvestigationalMedicinalProduct.RegulatorProductCode | |
| Definition | The product code (identifier) for the Investigational Medicinal Product as designated by the Medicines Regulatory Agency can be specified in text. Either this code or the sponsor product code (see 11.3. 2.2.4 ) shall be specified. (11.3.2.2.5) |
| Short | The product code (identifier) for the Investigational Medicinal Product as designated by the Medicines Regulatory Agency can be specified in text. Either this code or the sponsor product code (see 11.3. 2.2.4 ) shall be specified. (11.3.2.2.5) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 10. InvestigationalMedicinalProduct.PaediatricUseIndicator | |
| Definition | If the Investigational Medicinal Product refers to a specific paediatric formulation, this can be specified using a controlled vocabulary. A term and a term identifier shall be used. (11.3.2.2.6) |
| Short | If the Investigational Medicinal Product refers to a specific paediatric formulation, this can be specified using a controlled vocabulary. A term and a term identifier shall be used. (11.3.2.2.6) |
| Control | 0..1 |
| Type | CodeableConcept |
| 12. InvestigationalMedicinalProduct.ClinicalTrialStatus | |
| Definition | The status of the clinical trial has to be specified. See ISO / TS 20443 for more information and examples. (11.3.2.2.7) |
| Short | The status of the clinical trial has to be specified. See ISO / TS 20443 for more information and examples. (11.3.2.2.7) |
| Control | 0..1 |
| Type | CodeableConcept |
| 14. InvestigationalMedicinalProduct.OrphanDesignationStatus | |
| Definition | See 9.2.2.2.7 . (11.3.2.2.8) |
| Short | See 9.2.2.2.7 . (11.3.2.2.8) |
| Control | 0..1 |
| Type | CodeableConcept |
| 16. InvestigationalMedicinalProduct.AttachedDocument | |
| Definition | 11.3.2.6 |
| Short | 11.3.2.6 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 18. InvestigationalMedicinalProduct.AttachedDocument.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 20. InvestigationalMedicinalProduct.AttachedDocument.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.AttachedDocument.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 22. InvestigationalMedicinalProduct.AttachedDocument.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 24. InvestigationalMedicinalProduct.AttachedDocument.Identifier | |
| Definition | The reference to the regulatory decision document related to the granting of the authorisation or the latest update of the regulated product information shall be specified in text. (9.2.2.11.2) |
| Short | The reference to the regulatory decision document related to the granting of the authorisation or the latest update of the regulated product information shall be specified in text. (9.2.2.11.2) |
| Control | 1..1 |
| Type | Identifier |
| 26. InvestigationalMedicinalProduct.AttachedDocument.EffectiveDate | |
| Definition | The date corresponding to a version of a regulated document containing regulated Medicinal Product information (e.g. elements related to the summary of product characteristics, product labelling). A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE Document version date corresponds to the tracking versions of a regulated document. It does not correspond to the actual revisions or regulatory timelines that may be captured within a regulated document. (9.2.2.11.3) |
| Short | The date corresponding to a version of a regulated document containing regulated Medicinal Product information (e.g. elements related to the summary of product characteristics, product labelling). A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE Document version date corresponds to the tracking versions of a regulated document. It does not correspond to the actual revisions or regulatory timelines that may be captured within a regulated document. (9.2.2.11.3) |
| Control | 1..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 28. InvestigationalMedicinalProduct.AttachedDocument.Type | |
| Definition | The type of document that is supporting a version increment shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.11.4) |
| Short | The type of document that is supporting a version increment shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.11.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 30. InvestigationalMedicinalProduct.AttachedDocument.Content | |
| Definition | The actual document that is supporting a version increment shall be attached. The format of the document attachment shall be specified by regional implementations. (9.2.2.11.5) |
| Short | The actual document that is supporting a version increment shall be attached. The format of the document attachment shall be specified by regional implementations. (9.2.2.11.5) |
| Control | 1..1 |
| Type | base64Binary |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 32. InvestigationalMedicinalProduct.AttachedDocument.Language | |
| Definition | This attribute defines the language used for the information related to the regulatory submission. (9.2.2.11.6) |
| Short | This attribute defines the language used for the information related to the regulatory submission. (9.2.2.11.6) |
| Control | 0..1 |
| Type | CodeableConcept |
| 34. InvestigationalMedicinalProduct.AttachedDocument.MediaType | |
| Definition | This attributes is used to define the graphic media type of the attached document. (9.2.2.11.7) |
| Short | This attributes is used to define the graphic media type of the attached document. (9.2.2.11.7) |
| Control | 0..1 |
| Type | CodeableConcept |
| 36. InvestigationalMedicinalProduct.AttachedDocument.VersionNumber | |
| Definition | This is a number identifying a specific version of the attached regulatory document. (9.2.2.11.8) |
| Short | This is a number identifying a specific version of the attached regulatory document. (9.2.2.11.8) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 38. InvestigationalMedicinalProduct.AttachedDocument.VersionSetIdentifier | |
| Definition | This is a number used to group together a set of specific versions of the same regulatory document. (9.2.2.11.9) |
| Short | This is a number used to group together a set of specific versions of the same regulatory document. (9.2.2.11.9) |
| Control | 0..1 |
| Type | Identifier |
| 40. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation | |
| Definition | 11.4.2.2 |
| Short | 11.4.2.2 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 42. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 44. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 46. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 48. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.RegistrationNumber | |
| Definition | The registration number (identifier) for a clinical trial in a region shall be specified. (11.4.2.2.2) |
| Short | The registration number (identifier) for a clinical trial in a region shall be specified. (11.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 50. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.InvestigationCode | |
| Definition | The code for a particular investigation (trial) as assigned in a jurisdiction for a clinical trial shall be specified in text. (11.4.2.2.3) |
| Short | The code for a particular investigation (trial) as assigned in a jurisdiction for a clinical trial shall be specified in text. (11.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 52. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Country | |
| Definition | The jurisdiction(s) in which the clinical trial authorisation was granted shall be described using ISO 3166 - 1 alpha-2 code elements. (11.4.2.2.4) |
| Short | The jurisdiction(s) in which the clinical trial authorisation was granted shall be described using ISO 3166 - 1 alpha-2 code elements. (11.4.2.2.4) |
| Control | 1..* |
| Type | CodeableConcept |
| 54. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.ProtocolNumber | |
| Definition | The number assigned to the clinical trial protocol shall be specified. (11.4.2.2.5) |
| Short | The number assigned to the clinical trial protocol shall be specified. (11.4.2.2.5) |
| Control | 1..1 |
| Type | Identifier |
| 56. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.AuthorisationDate | |
| Definition | The date when the clinical trial authorisation was granted by a Medicines Regulatory Agency in a jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.2.6) |
| Short | The date when the clinical trial authorisation was granted by a Medicines Regulatory Agency in a jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.2.6) |
| Control | 1..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 58. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.AnticipatedEndDate | |
| Definition | The date when the clinical trial is anticipated to be completed in accordance with the authorised clinical trial protocol in a jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.2.7) |
| Short | The date when the clinical trial is anticipated to be completed in accordance with the authorised clinical trial protocol in a jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.2.7) |
| Control | 1..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 60. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.LocalClinicalTrialAuthorisation | |
| Definition | 11.4.2.3 |
| Short | 11.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 62. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.LocalClinicalTrialAuthorisation.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 64. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.LocalClinicalTrialAuthorisation.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.LocalClinicalTrialAuthorisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 66. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.LocalClinicalTrialAuthorisation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 68. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.LocalClinicalTrialAuthorisation.LocalClinicalTrialRegistrationNumber | |
| Definition | The registration number (identifier) for a clinical trial as assigned by the Regulatory Medicines Authority locally shall be specified in text. (11.4.2.3.2) |
| Short | The registration number (identifier) for a clinical trial as assigned by the Regulatory Medicines Authority locally shall be specified in text. (11.4.2.3.2) |
| Control | 1..1 |
| Type | Identifier |
| 70. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.LocalClinicalTrialAuthorisation.LocalInvestigationCode | |
| Definition | The “code” for an Investigational Medicinal Product as assigned locally for a clinical trial of a set of clinical trials shall be specified in text. (11.4.2.3.3) |
| Short | The “code” for an Investigational Medicinal Product as assigned locally for a clinical trial of a set of clinical trials shall be specified in text. (11.4.2.3.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 72. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.LocalClinicalTrialAuthorisation.Jurisdiction | |
| Definition | The jurisdiction(s) in which the clinical trial authorisation was granted shall be described using ISO 3166 - 1 alpha-2 code elements. (11.4.2.3.4) |
| Short | The jurisdiction(s) in which the clinical trial authorisation was granted shall be described using ISO 3166 - 1 alpha-2 code elements. (11.4.2.3.4) |
| Control | 1..* |
| Type | CodeableConcept |
| 74. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.LocalClinicalTrialAuthorisation.LocalAuthorisationDate | |
| Definition | The date when the clinical trial authorisation was granted locally by a Regulatory Medicines Authority shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.3.5) |
| Short | The date when the clinical trial authorisation was granted locally by a Regulatory Medicines Authority shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.3.5) |
| Control | 1..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 76. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.LocalClinicalTrialAuthorisation.LocalAnticipatedEndDate | |
| Definition | The date when the clinical trial is anticipated to be completed in accordance with the authorised clinical trial protocol shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.3.6) |
| Short | The date when the clinical trial is anticipated to be completed in accordance with the authorised clinical trial protocol shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.3.6) |
| Control | 1..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 78. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation | |
| Definition | 9.3.2.5 |
| Short | 9.3.2.5 |
| Control | 1..1 |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 80. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 82. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 84. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 86. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 88. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 90. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 92. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 94. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 96. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 98. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 100. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 102. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 104. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 106. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 108. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 110. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 112. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 114. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 116. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 118. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 120. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 122. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 124. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 126. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 128. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 130. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation | |
| Definition | 11.4.2.4 |
| Short | 11.4.2.4 |
| Control | 1..1 |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 132. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 134. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 136. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 138. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 140. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 142. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 144. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 146. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 148. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 150. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Contact.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 152. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Contact.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 154. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Contact.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 156. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 158. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 160. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 162. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 164. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 166. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.OtherLocations.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 168. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.OtherLocations.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 170. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.OtherLocations.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 172. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 174. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 176. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 178. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 180. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 182. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.SME | |
| Definition | 9.3.2.4 |
| Short | 9.3.2.4 |
| Control | 0..1 |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 184. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.SME.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 186. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.SME.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor_Organisation.SME.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 188. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.SME.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 190. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.SME.SMEFlag | |
| Definition | This is a flag to indicate if the organisation is an SME. (9.3.2.4.1) |
| Short | This is a flag to indicate if the organisation is an SME. (9.3.2.4.1) |
| Control | 1..1 |
| Type | Element(BL) |
| 192. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.SME.Size | |
| Definition | The size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2) |
| Short | The size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2) |
| Control | 0..1 |
| Type | CodeableConcept |
| 194. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.SME.SMENumber | |
| Definition | This is a unique number that it is uniquely identifying an SME. (9.3.2.4.3) |
| Short | This is a unique number that it is uniquely identifying an SME. (9.3.2.4.3) |
| Control | 0..1 |
| Type | Identifier |
| 196. InvestigationalMedicinalProduct.ClinicalTrialAuthorisation.Sponsor-Organisation.SME.StatusDate | |
| Definition | This is the date when the SME status was granted. (9.3.2.4.4) |
| Short | This is the date when the SME status was granted. (9.3.2.4.4) |
| Control | 0..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 198. InvestigationalMedicinalProduct.Contraindication | |
| Definition | 9.9.2.3 |
| Short | 9.9.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 200. InvestigationalMedicinalProduct.Contraindication.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 202. InvestigationalMedicinalProduct.Contraindication.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.Contraindication.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 204. InvestigationalMedicinalProduct.Contraindication.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 206. InvestigationalMedicinalProduct.Contraindication.ContraindicationsText | |
| Definition | The text of the contraindication(s) in line with the regulated product information shall be described. (9.9.2.3.2) |
| Short | The text of the contraindication(s) in line with the regulated product information shall be described. (9.9.2.3.2) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 208. InvestigationalMedicinalProduct.Contraindication.ContraindicationsAsDisease-Symptom-Procedure | |
| Definition | The underlying disease, symptom or procedure of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.3) |
| Short | The underlying disease, symptom or procedure of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.3) |
| Control | 0..1 |
| Type | CodeableConcept |
| 210. InvestigationalMedicinalProduct.Contraindication.DiseaseStatus | |
| Definition | The status of the disease or symptom of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.4) |
| Short | The status of the disease or symptom of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.4) |
| Control | 0..1 |
| Type | CodeableConcept |
| 212. InvestigationalMedicinalProduct.Contraindication.Comorbidity | |
| Definition | The comorbidity (concurrent condition) or coinfection shall be specified. (9.9.2.3.5) |
| Short | The comorbidity (concurrent condition) or coinfection shall be specified. (9.9.2.3.5) |
| Control | 0..* |
| Type | CodeableConcept |
| 214. InvestigationalMedicinalProduct.Contraindication.OtherTherapySpecifics | |
| Definition | 9.9.2.6 |
| Short | 9.9.2.6 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 216. InvestigationalMedicinalProduct.Contraindication.OtherTherapySpecifics.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 218. InvestigationalMedicinalProduct.Contraindication.OtherTherapySpecifics.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.Contraindication.OtherTherapySpecifics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 220. InvestigationalMedicinalProduct.Contraindication.OtherTherapySpecifics.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 222. InvestigationalMedicinalProduct.Contraindication.OtherTherapySpecifics.TherapyRelationshipType | |
| Definition | The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2) |
| Short | The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 224. InvestigationalMedicinalProduct.Contraindication.OtherTherapySpecifics.Medication | |
| Definition | Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3) |
| Short | Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3) |
| Control | 1..1 |
| Type | CodeableConcept |
| 226. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics | |
| Definition | 9.9.2.5 |
| Short | 9.9.2.5 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 228. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 230. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 232. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 234. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics.Age | |
| Definition | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) |
| Short | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) |
| Control | 0..1 |
| Type | CodeableConcept |
| 236. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics.AgeRangeLow | |
| Definition | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) |
| Short | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) |
| Control | 0..1 |
| Type | Quantity |
| 238. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics.AgeRangeHigh | |
| Definition | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) |
| Short | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) |
| Control | 0..1 |
| Type | Quantity |
| 240. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics.Gender | |
| Definition | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) |
| Short | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 242. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics.Race | |
| Definition | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) |
| Short | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) |
| Control | 0..1 |
| Type | CodeableConcept |
| 244. InvestigationalMedicinalProduct.Contraindication.PopulationSpecifics.PhysiologicalCondition | |
| Definition | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) |
| Short | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) |
| Control | 0..1 |
| Type | CodeableConcept |
| 246. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication | |
| Definition | 9.9.2.2 |
| Short | 9.9.2.2 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 248. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 250. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 252. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 254. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.IndicationText | |
| Definition | The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2) |
| Short | The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 256. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.IndicationAsDisease-Symptom-Procedure | |
| Definition | The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3) |
| Short | The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3) |
| Control | 0..1 |
| Type | CodeableConcept |
| 258. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.DiseaseStatus | |
| Definition | The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4) |
| Short | The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4) |
| Control | 0..1 |
| Type | CodeableConcept |
| 260. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.Comorbidity | |
| Definition | If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5) |
| Short | If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5) |
| Control | 0..* |
| Type | CodeableConcept |
| 262. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.IntendedEffect | |
| Definition | The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6) |
| Short | The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6) |
| Control | 0..1 |
| Type | CodeableConcept |
| 264. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.Timing-Duration | |
| Definition | If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7) |
| Short | If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7) |
| Control | 0..1 |
| Type | Quantity |
| 266. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics | |
| Definition | 9.9.2.6 |
| Short | 9.9.2.6 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 268. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 270. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 272. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 274. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.TherapyRelationshipType | |
| Definition | The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2) |
| Short | The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 276. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.Medication | |
| Definition | Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3) |
| Short | Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3) |
| Control | 1..1 |
| Type | CodeableConcept |
| 278. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics | |
| Definition | 9.9.2.5 |
| Short | 9.9.2.5 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 280. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 282. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 284. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 286. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.Age | |
| Definition | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) |
| Short | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) |
| Control | 0..1 |
| Type | CodeableConcept |
| 288. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.AgeRangeLow | |
| Definition | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) |
| Short | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) |
| Control | 0..1 |
| Type | Quantity |
| 290. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.AgeRangeHigh | |
| Definition | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) |
| Short | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) |
| Control | 0..1 |
| Type | Quantity |
| 292. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.Gender | |
| Definition | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) |
| Short | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 294. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.Race | |
| Definition | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) |
| Short | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) |
| Control | 0..1 |
| Type | CodeableConcept |
| 296. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.PhysiologicalCondition | |
| Definition | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) |
| Short | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) |
| Control | 0..1 |
| Type | CodeableConcept |
| 298. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects | |
| Definition | 9.9.2.4 |
| Short | 9.9.2.4 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 300. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 302. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 304. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 306. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.UndesirableEffectText | |
| Definition | The text of the undesirable effect shall be given. (9.9.2.4.2) |
| Short | The text of the undesirable effect shall be given. (9.9.2.4.2) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 308. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.UndesirableEffectAsSymptom-Condition-Effect | |
| Definition | The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3) |
| Short | The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3) |
| Control | 0..1 |
| Type | CodeableConcept |
| 310. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.Symptom-Condition-EffectClassification | |
| Definition | The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4) |
| Short | The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4) |
| Control | 0..1 |
| Type | CodeableConcept |
| 312. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.FrequencyOfOccurrence | |
| Definition | The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5) |
| Short | The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 314. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics | |
| Definition | 9.9.2.5 |
| Short | 9.9.2.5 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 316. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 318. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 320. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 322. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Age | |
| Definition | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) |
| Short | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) |
| Control | 0..1 |
| Type | CodeableConcept |
| 324. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeLow | |
| Definition | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) |
| Short | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) |
| Control | 0..1 |
| Type | Quantity |
| 326. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeHigh | |
| Definition | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) |
| Short | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) |
| Control | 0..1 |
| Type | Quantity |
| 328. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Gender | |
| Definition | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) |
| Short | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 330. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Race | |
| Definition | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) |
| Short | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) |
| Control | 0..1 |
| Type | CodeableConcept |
| 332. InvestigationalMedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.PhysiologicalCondition | |
| Definition | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) |
| Short | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) |
| Control | 0..1 |
| Type | CodeableConcept |
| 334. InvestigationalMedicinalProduct.Header | |
| Definition | 11.3.2.5 |
| Short | 11.3.2.5 |
| Control | 1..1 |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 336. InvestigationalMedicinalProduct.Header.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 338. InvestigationalMedicinalProduct.Header.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.Header.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 340. InvestigationalMedicinalProduct.Header.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 342. InvestigationalMedicinalProduct.Header.Identifier | |
| Definition | This attribute is for the unique code identifying the regulatory information submission. (9.2.2.10.2) |
| Short | This attribute is for the unique code identifying the regulatory information submission. (9.2.2.10.2) |
| Control | 1..1 |
| Type | Identifier |
| 344. InvestigationalMedicinalProduct.Header.EffectiveDate | |
| Definition | The date specified in the regulatory decision document by which the authorisation or the updates to the regulated product information become effective shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.2.2.10.3) |
| Short | The date specified in the regulatory decision document by which the authorisation or the updates to the regulated product information become effective shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.2.2.10.3) |
| Control | 1..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 346. InvestigationalMedicinalProduct.Header.Language | |
| Definition | This attribute defines the language used for the information related to the regulatory submission. (9.2.2.10.4) |
| Short | This attribute defines the language used for the information related to the regulatory submission. (9.2.2.10.4) |
| Control | 0..1 |
| Type | CodeableConcept |
| 348. InvestigationalMedicinalProduct.Header.VersionNumber | |
| Definition | This is a number identifying a specific version of the regulatory information submission. (9.2.2.10.5) |
| Short | This is a number identifying a specific version of the regulatory information submission. (9.2.2.10.5) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 350. InvestigationalMedicinalProduct.Header.VersionSetIdentifier | |
| Definition | This is a number used to group together a set of specific versions of the regulatory information submission. (9.2.2.10.6) |
| Short | This is a number used to group together a set of specific versions of the regulatory information submission. (9.2.2.10.6) |
| Control | 0..1 |
| Type | Identifier |
| 352. InvestigationalMedicinalProduct.Interactions | |
| Definition | 9.9.2.7 |
| Short | 9.9.2.7 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 354. InvestigationalMedicinalProduct.Interactions.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 356. InvestigationalMedicinalProduct.Interactions.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.Interactions.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 358. InvestigationalMedicinalProduct.Interactions.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 360. InvestigationalMedicinalProduct.Interactions.InteractionsText | |
| Definition | The text of the interaction in accordance with the regulated product information shall be provided. (9.9.2.7.2) |
| Short | The text of the interaction in accordance with the regulated product information shall be provided. (9.9.2.7.2) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 362. InvestigationalMedicinalProduct.Interactions.Interactant | |
| Definition | This element can be used to describe the specific medication, food or laboratory test that is the secondary interactant of the interaction as described in the regulated product information. For more information, refer to regional implementation guides. (9.9.2.7.3) |
| Short | This element can be used to describe the specific medication, food or laboratory test that is the secondary interactant of the interaction as described in the regulated product information. For more information, refer to regional implementation guides. (9.9.2.7.3) |
| Control | 0..* |
| Type | CodeableConcept |
| 364. InvestigationalMedicinalProduct.Interactions.InteractionsType | |
| Definition | The type of interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.4) |
| Short | The type of interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.4) |
| Control | 0..1 |
| Type | CodeableConcept |
| 366. InvestigationalMedicinalProduct.Interactions.InteractionsEffect | |
| Definition | The effect of the interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.5) |
| Short | The effect of the interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 368. InvestigationalMedicinalProduct.Interactions.InteractionsIncidence | |
| Definition | The incidence of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.6) |
| Short | The incidence of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.6) |
| Control | 0..1 |
| Type | CodeableConcept |
| 370. InvestigationalMedicinalProduct.Interactions.ManagementActions | |
| Definition | The actions to provide management of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.7) |
| Short | The actions to provide management of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.7) |
| Control | 0..1 |
| Type | CodeableConcept |
| 372. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName | |
| Definition | 11.3.2.8 |
| Short | 11.3.2.8 |
| Control | 1..1 |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 374. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 376. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 378. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 380. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.FullName | |
| Definition | The full and complete Investigational Medicinal Product name as assigned by the sponsor can be specified as text. Unlike the authorised Medicinal Product name, this information is not mandatory for Investigational Medicinal Products, but either this attribute or the product code attribute below shall be valued. (11.3.2.8.1) |
| Short | The full and complete Investigational Medicinal Product name as assigned by the sponsor can be specified as text. Unlike the authorised Medicinal Product name, this information is not mandatory for Investigational Medicinal Products, but either this attribute or the product code attribute below shall be valued. (11.3.2.8.1) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 382. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.Code | |
| Definition | The Investigational Medicinal Product may, in its initial development, be described by an informal “code” rather than by name; this shall be specified here, where applicable. For all the other name part attributes, the information is as described previously in 9.2.2.8 . (11.3.2.8.2) |
| Short | The Investigational Medicinal Product may, in its initial development, be described by an informal “code” rather than by name; this shall be specified here, where applicable. For all the other name part attributes, the information is as described previously in 9.2.2.8 . (11.3.2.8.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 384. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.InventedNamePart | |
| Definition | The invented name (i.e. trade name) of the Medicinal Product without the trademark or any other similar designations reflected in the Medicinal Product name can be specified as text, where applicable. (9.2.2.8.3) |
| Short | The invented name (i.e. trade name) of the Medicinal Product without the trademark or any other similar designations reflected in the Medicinal Product name can be specified as text, where applicable. (9.2.2.8.3) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 386. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.ScientificNamePart | |
| Definition | The scientific or common (i.e. generic) name of the Medicinal Product without any other descriptors can be specified as text, where applicable. (9.2.2.8.4) |
| Short | The scientific or common (i.e. generic) name of the Medicinal Product without any other descriptors can be specified as text, where applicable. (9.2.2.8.4) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 388. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.StrengthPart | |
| Definition | The strength, if reflected in the Medicinal Product name, can be specified as text, where applicable. This strength name part can differ from the concept of “Strength” as described in 9.7 . (9.2.2.8.5) |
| Short | The strength, if reflected in the Medicinal Product name, can be specified as text, where applicable. This strength name part can differ from the concept of “Strength” as described in 9.7 . (9.2.2.8.5) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 390. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.PharmaceuticalDoseFormPart | |
| Definition | The pharmaceutical dose form, if reflected in the Medicinal Product name, can be specified as text, where applicable. This pharmaceutical dose form name part can differ from the concept of administrable dose form and manufactured dose form as described in ISO / TS 20443 . (9.2.2.8.6) |
| Short | The pharmaceutical dose form, if reflected in the Medicinal Product name, can be specified as text, where applicable. This pharmaceutical dose form name part can differ from the concept of administrable dose form and manufactured dose form as described in ISO / TS 20443 . (9.2.2.8.6) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 392. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.FormulationPart | |
| Definition | The formulation, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.7) |
| Short | The formulation, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.7) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 394. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.IntendedUsePart | |
| Definition | The intended use, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.8) |
| Short | The intended use, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.8) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 396. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.TargetPopulationPart | |
| Definition | The target population, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.9) |
| Short | The target population, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.9) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 398. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.ContainerOrPackPart | |
| Definition | The container or pack, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.10) |
| Short | The container or pack, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.10) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 400. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.DevicePart | |
| Definition | The device, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.11) |
| Short | The device, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.11) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 402. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.TrademarkOrCompanyNamePart | |
| Definition | The trademark, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.12) |
| Short | The trademark, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.12) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 404. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.Time-PeriodPart | |
| Definition | The time/period, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.13) |
| Short | The time/period, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.13) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 406. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.FlavourPart | |
| Definition | The flavour, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.14) |
| Short | The flavour, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.14) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 408. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.DelimiterPart | |
| Definition | A delimiter separates one composite in a segment from another or separates one subcomposite from another. (9.2.2.8.15) |
| Short | A delimiter separates one composite in a segment from another or separates one subcomposite from another. (9.2.2.8.15) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 410. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.Country-Language | |
| Definition | 9.2.2.9 |
| Short | 9.2.2.9 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 412. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.Country-Language.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 414. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.Country-Language.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.Country-Language.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 416. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.Country-Language.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 418. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.Country-Language.Country | |
| Definition | The country where the Medicinal Product name is applicable shall be described using ISO 3166 - 1 alpha-2 code elements. (9.2.2.9.2) |
| Short | The country where the Medicinal Product name is applicable shall be described using ISO 3166 - 1 alpha-2 code elements. (9.2.2.9.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 420. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.Country-Language.Jurisdiction | |
| Definition | The jurisdiction within the country where the Medicinal Product name is applicable can be described using an appropriate controlled vocabulary, if appropriate. The controlled term and the controlled term identifier shall be specified. (9.2.2.9.3) |
| Short | The jurisdiction within the country where the Medicinal Product name is applicable can be described using an appropriate controlled vocabulary, if appropriate. The controlled term and the controlled term identifier shall be specified. (9.2.2.9.3) |
| Control | 0..1 |
| Type | CodeableConcept |
| 422. InvestigationalMedicinalProduct.InvestigationalMedicinalProductName.Country-Language.Language | |
| Definition | The language of the Medicinal Product name as applicable in the specified country and jurisdiction if appropriate shall be specified using ISO 639 - 1 . (9.2.2.9.4) |
| Short | The language of the Medicinal Product name as applicable in the specified country and jurisdiction if appropriate shall be specified using ISO 639 - 1 . (9.2.2.9.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 424. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct | |
| Definition | 11.2.7 |
| Short | 11.2.7 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 426. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 428. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 430. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 432. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.IPCID | |
| Definition | This is the unique identifier for the Packaged Medicinal Product, constructed as described in 8.3 . (9.6.2.2.1) |
| Short | This is the unique identifier for the Packaged Medicinal Product, constructed as described in 8.3 . (9.6.2.2.1) |
| Control | 1..1 |
| Type | Identifier |
| 434. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageDescription | |
| Definition | A textual description of the Packaged Medicinal Product shall be provided. (9.6.2.2.2) |
| Short | A textual description of the Packaged Medicinal Product shall be provided. (9.6.2.2.2) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 436. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.BatchIdentifier | |
| Definition | 9.6.2.8 |
| Short | 9.6.2.8 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 438. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.BatchIdentifier.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 440. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.BatchIdentifier.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.BatchIdentifier.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 442. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.BatchIdentifier.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 444. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.BatchIdentifier.BAID1 | |
| Definition | The BAID1, which appears on the outer packaging of a specific batch of the Medicinal Product, shall be specified. Since there will be many different batches of any one Packaged Medicinal Product, and since the specification of batch identification might not always be required for each type of Packaged Medicinal Product, the cardinality of the relationship between the Packaged Medicinal Product and the batch identifier is given as 0...*. In situations where a Packaged Medicinal Product contains more than one manufactured item and/or includes a device, this batch number refers to the one given on the outermost packaging. (9.6.2.8.1) |
| Short | The BAID1, which appears on the outer packaging of a specific batch of the Medicinal Product, shall be specified. Since there will be many different batches of any one Packaged Medicinal Product, and since the specification of batch identification might not always be required for each type of Packaged Medicinal Product, the cardinality of the relationship between the Packaged Medicinal Product and the batch identifier is given as 0...*. In situations where a Packaged Medicinal Product contains more than one manufactured item and/or includes a device, this batch number refers to the one given on the outermost packaging. (9.6.2.8.1) |
| Control | 1..1 |
| Type | Identifier |
| 446. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.BatchIdentifier.BAID2 | |
| Definition | The BAID2, which appears on the immediate packaging and is not the outer packaging, shall be specified. (9.6.2.8.2) |
| Short | The BAID2, which appears on the immediate packaging and is not the outer packaging, shall be specified. (9.6.2.8.2) |
| Control | 0..1 |
| Type | Identifier |
| 448. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.BatchIdentifier.ExpirationDate | |
| Definition | This is the date the manufacturer guarantees the full potency and safety of a particular batch/lot of Medicinal Product. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.6.2.8.3) |
| Short | This is the date the manufacturer guarantees the full potency and safety of a particular batch/lot of Medicinal Product. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.6.2.8.3) |
| Control | 1..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 450. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation | |
| Definition | 9.5.2.2 |
| Short | 9.5.2.2 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 452. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 454. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 456. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 458. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 460. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 462. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 464. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 466. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 468. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 470. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 472. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 474. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 476. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 478. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 480. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 482. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 484. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 486. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 488. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 490. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 492. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 494. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 496. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 498. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 500. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 502. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation | |
| Definition | 9.5.2.3 |
| Short | 9.5.2.3 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 504. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 506. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 508. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 510. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType | |
| Definition | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Short | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 512. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber | |
| Definition | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Short | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Control | 0..1 |
| Type | Identifier |
| 514. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate | |
| Definition | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Short | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Control | 0..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 516. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator | |
| Definition | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Short | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 518. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation | |
| Definition | 9.3.2.5 |
| Short | 9.3.2.5 |
| Control | 0..1 |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 520. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 522. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 524. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 526. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 528. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 530. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 532. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 534. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 536. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 538. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 540. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 542. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 544. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 546. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 548. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 550. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 552. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 554. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 556. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 558. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 560. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 562. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 564. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 566. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 568. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 570. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container | |
| Definition | 9.6.2.3 |
| Short | 9.6.2.3 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 572. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 574. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 576. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 578. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PackageItem-ContainerType | |
| Definition | The package item (container) type shall be specified to describe the physical type of the container of the medicine in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. A term and a term identifier shall be specified. (9.6.2.3.2) |
| Short | The package item (container) type shall be specified to describe the physical type of the container of the medicine in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. A term and a term identifier shall be specified. (9.6.2.3.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 580. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PackageItem-ContainerQuantity | |
| Definition | The quantity (or count number) of the package item shall be specified. Because the package item class recurses to describe containers within containers, the first (outermost) container shall always have a quantity of “1”. (9.6.2.3.3) |
| Short | The quantity (or count number) of the package item shall be specified. Because the package item class recurses to describe containers within containers, the first (outermost) container shall always have a quantity of “1”. (9.6.2.3.3) |
| Control | 1..1 |
| Type | Quantity |
| 582. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Material | |
| Definition | The material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology as applicable. A term and a term identifier shall be specified. (9.6.2.3.4) |
| Short | The material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology as applicable. A term and a term identifier shall be specified. (9.6.2.3.4) |
| Control | 1..* |
| Type | CodeableConcept |
| 584. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.AlternateMaterial | |
| Definition | The alternate material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 1 9844 and its resulting terminology as applicable. A term and a term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a blister sleeve). (9.6.2.3.5) |
| Short | The alternate material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 1 9844 and its resulting terminology as applicable. A term and a term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a blister sleeve). (9.6.2.3.5) |
| Control | 0..* |
| Type | CodeableConcept |
| 586. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier | |
| Definition | 9.6.2.4 |
| Short | 9.6.2.4 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 588. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 590. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.DataCarrierIdentifier.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 592. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 594. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier.CodeSystem | |
| Definition | The data carrier identification system itself shall be specified using an appropriate identification system. (9.6.2.4.2) |
| Short | The data carrier identification system itself shall be specified using an appropriate identification system. (9.6.2.4.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 596. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier.Value | |
| Definition | The individual value from the identification system that applies to the Packaged Medicinal Product shall be specified. (9.6.2.4.3) |
| Short | The individual value from the identification system that applies to the Packaged Medicinal Product shall be specified. (9.6.2.4.3) |
| Control | 1..1 |
| Type | CodeableConcept |
| 598. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device | |
| Definition | 9.6.2.12 |
| Short | 9.6.2.12 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 600. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 602. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Device.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 604. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 606. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceType | |
| Definition | The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2) |
| Short | The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 608. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceTradeName | |
| Definition | This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3) |
| Short | This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 610. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceQuantity | |
| Definition | The quantity of the device present in the pack shall be specified. (9.6.2.12.4) |
| Short | The quantity of the device present in the pack shall be specified. (9.6.2.12.4) |
| Control | 1..1 |
| Type | Quantity |
| 612. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceListingNumber | |
| Definition | This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5) |
| Short | This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 614. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceIdentifier | |
| Definition | A unique device identifier needs to be specified. (9.6.2.12.6) |
| Short | A unique device identifier needs to be specified. (9.6.2.12.6) |
| Control | 0..1 |
| Type | Identifier |
| 616. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.ModelNumber | |
| Definition | This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7) |
| Short | This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 618. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.SterilityIndicator | |
| Definition | Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8) |
| Short | Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8) |
| Control | 0..1 |
| Type | CodeableConcept |
| 620. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.SterilisationRequirementIndicator | |
| Definition | Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9) |
| Short | Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9) |
| Control | 0..1 |
| Type | CodeableConcept |
| 622. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceUsage | |
| Definition | The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10) |
| Short | The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10) |
| Control | 0..1 |
| Type | CodeableConcept |
| 624. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier | |
| Definition | 11.12 |
| Short | 11.12 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 626. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 628. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Device.DeviceBatchIdentifier.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 630. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 632. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier.BatchNumber | |
| Definition | Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2) |
| Short | Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 634. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier.ExpirationDate | |
| Definition | Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3) |
| Short | Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3) |
| Control | 1..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 636. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial | |
| Definition | 9.6.2.13 |
| Short | 9.6.2.13 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 638. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 640. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Device.DeviceMaterial.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 642. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 644. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.Substance | |
| Definition | The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2) |
| Short | The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 646. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.Alternate | |
| Definition | This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3) |
| Short | This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3) |
| Control | 0..1 |
| Type | Element(BL) |
| 648. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.AllergenicIndicator | |
| Definition | This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4) |
| Short | This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4) |
| Control | 0..1 |
| Type | Element(BL) |
| 650. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature | |
| Definition | 11.11 |
| Short | 11.11 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 652. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 654. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Device.DeviceNomenclature.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 656. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 658. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature.CodeSystem | |
| Definition | The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2) |
| Short | The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 660. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature.Value | |
| Definition | The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3) |
| Short | The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3) |
| Control | 1..1 |
| Type | CodeableConcept |
| 662. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation | |
| Definition | 9.5.2.2 |
| Short | 9.5.2.2 |
| Control | 0..1 |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 664. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 666. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 668. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 670. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 672. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 674. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 676. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 678. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 680. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 682. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 684. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 686. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 688. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 690. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 692. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 694. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 696. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 698. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 700. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 702. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 704. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 706. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 708. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 710. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 712. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 714. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation | |
| Definition | 9.5.2.3 |
| Short | 9.5.2.3 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 716. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 718. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 720. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 722. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType | |
| Definition | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Short | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 724. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber | |
| Definition | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Short | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Control | 0..1 |
| Type | Identifier |
| 726. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate | |
| Definition | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Short | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Control | 0..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 728. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator | |
| Definition | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Short | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 730. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation | |
| Definition | 9.3.2.5 |
| Short | 9.3.2.5 |
| Control | 0..1 |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 732. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 734. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 736. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 738. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 740. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 742. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 744. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 746. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 748. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 750. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 752. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 754. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 756. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 758. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 760. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 762. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 764. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 766. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 768. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 770. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 772. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 774. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 776. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 778. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 780. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 782. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics | |
| Definition | 9.6.2.22 |
| Short | 9.6.2.22 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 784. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 786. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Device.OtherCharacteristics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 788. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 790. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics.CodeSystem | |
| Definition | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) |
| Short | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 792. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics.Value | |
| Definition | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) |
| Short | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) |
| Control | 1..1 |
| Type | CodeableConcept |
| 794. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics | |
| Definition | 11.13 |
| Short | 11.13 |
| Control | 0..1 |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 796. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 798. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 800. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 802. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Height | |
| Definition | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) |
| Short | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) |
| Control | 0..1 |
| Type | Quantity |
| 804. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Width | |
| Definition | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) |
| Short | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) |
| Control | 0..1 |
| Type | Quantity |
| 806. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Depth | |
| Definition | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) |
| Short | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) |
| Control | 0..1 |
| Type | Quantity |
| 808. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Weight | |
| Definition | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) |
| Short | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) |
| Control | 0..1 |
| Type | Quantity |
| 810. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.NominalVolume | |
| Definition | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) |
| Short | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) |
| Control | 0..1 |
| Type | Quantity |
| 812. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.ExternalDiameter | |
| Definition | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) |
| Short | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) |
| Control | 0..1 |
| Type | Quantity |
| 814. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Shape | |
| Definition | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) |
| Short | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 816. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Colour | |
| Definition | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) |
| Short | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 818. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Imprint | |
| Definition | Where applicable, the imprint can be specified as text. (9.6.2.21.10) |
| Short | Where applicable, the imprint can be specified as text. (9.6.2.21.10) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 820. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Image | |
| Definition | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) |
| Short | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) |
| Control | 0..* |
| Type | base64Binary |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 822. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Scoring | |
| Definition | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) |
| Short | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) |
| Control | 0..1 |
| Type | CodeableConcept |
| 824. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage | |
| Definition | 9.6.2.11 |
| Short | 9.6.2.11 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 826. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 828. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Device.ShelfLife-Storage.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 830. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 832. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.ShelfLifeType | |
| Definition | This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2) |
| Short | This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 834. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.ShelfLifeTimePeriod | |
| Definition | The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3) |
| Short | The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3) |
| Control | 1..1 |
| Type | Quantity |
| 836. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.SpecialPrecautionsForStorage | |
| Definition | Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4) |
| Short | Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4) |
| Control | 0..* |
| Type | CodeableConcept |
| 838. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem | |
| Definition | 9.6.2.20 |
| Short | 9.6.2.20 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 840. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 842. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 844. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 846. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.ManufacturedDoseForm | |
| Definition | This describes the pharmaceutical dose form of the manufactured item, where applicable, before transformation into the pharmaceutical product. The manufactured dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. A Medicinal Product may have two package items, e.g. one with a manufactured dose form of powder for solution for injection and the other with a manufactured dose form of solvent for solution for injection. These are then to be transformed to a solution for injection before the medicine can be administered to a patient. Powder and solvent for solution for injection is the “combined pharmaceutical dose form”, which is an attribute of “Medicinal Product” and solution for injection is the “administrable dose form”, which is an attribute of “pharmaceutical product”. (9.6.2.20.2) |
| Short | This describes the pharmaceutical dose form of the manufactured item, where applicable, before transformation into the pharmaceutical product. The manufactured dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. A Medicinal Product may have two package items, e.g. one with a manufactured dose form of powder for solution for injection and the other with a manufactured dose form of solvent for solution for injection. These are then to be transformed to a solution for injection before the medicine can be administered to a patient. Powder and solvent for solution for injection is the “combined pharmaceutical dose form”, which is an attribute of “Medicinal Product” and solution for injection is the “administrable dose form”, which is an attribute of “pharmaceutical product”. (9.6.2.20.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 848. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.UnitOfPresentation | |
| Definition | This specifies the “real world” units in which the quantity of the manufactured item is described. The unit of presentation can be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. For items where their quantity is a measured quantity of weight or volume, the “unit of presentation” shall not be given since it is the same as the units of that quantity (that is ml, mg or %). For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.3) |
| Short | This specifies the “real world” units in which the quantity of the manufactured item is described. The unit of presentation can be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. For items where their quantity is a measured quantity of weight or volume, the “unit of presentation” shall not be given since it is the same as the units of that quantity (that is ml, mg or %). For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.3) |
| Control | 0..1 |
| Type | CodeableConcept |
| 850. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.ManufacturedItemQuantity | |
| Definition | The quantity (or count number) of the manufactured item shall be described. It shall be specified as a value and units, and the units shall be specified as a symbol and a symbol identifier as defined in ISO 11240 and the resulting terminology. For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.4) |
| Short | The quantity (or count number) of the manufactured item shall be described. It shall be specified as a value and units, and the units shall be specified as a symbol and a symbol identifier as defined in ISO 11240 and the resulting terminology. For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.4) |
| Control | 1..1 |
| Type | Quantity |
| 852. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient | |
| Definition | 11.2.9 |
| Short | 11.2.9 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 854. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 856. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 858. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 860. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.IngredientRole | |
| Definition | The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2) |
| Short | The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 862. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.AllergenicIndicator | |
| Definition | This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3) |
| Short | This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3) |
| Control | 0..1 |
| Type | Element(BL) |
| 864. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation | |
| Definition | 9.5.2.2 |
| Short | 9.5.2.2 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 866. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 868. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 870. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 872. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 874. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 876. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 878. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 880. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 882. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 884. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 886. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 888. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 890. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 892. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 894. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 896. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 898. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 900. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 902. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 904. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 906. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 908. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 910. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 912. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 914. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 916. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation | |
| Definition | 9.5.2.3 |
| Short | 9.5.2.3 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 918. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 920. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 922. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 924. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType | |
| Definition | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Short | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 926. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber | |
| Definition | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Short | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Control | 0..1 |
| Type | Identifier |
| 928. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate | |
| Definition | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Short | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Control | 0..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 930. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator | |
| Definition | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Short | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 932. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation | |
| Definition | 9.3.2.5 |
| Short | 9.3.2.5 |
| Control | 0..1 |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 934. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 936. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 938. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 940. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 942. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 944. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 946. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 948. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 950. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 952. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 954. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 956. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 958. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 960. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 962. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 964. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 966. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 968. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 970. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 972. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 974. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 976. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 978. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 980. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 982. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 984. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance | |
| Definition | 9.7.2.4 |
| Short | 9.7.2.4 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 986. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 988. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 990. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 992. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.SpecifiedSubstance | |
| Definition | When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2) |
| Short | When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 994. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.SpecifiedSubstanceGroup | |
| Definition | The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3) |
| Short | The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3) |
| Control | 1..1 |
| Type | CodeableConcept |
| 996. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.ConfidentialityIndicator | |
| Definition | The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4) |
| Short | The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4) |
| Control | 0..1 |
| Type | CodeableConcept |
| 998. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength | |
| Definition | 9.7.2.5 |
| Short | 9.7.2.5 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1000. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1002. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1004. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1006. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Strength-Presentation | |
| Definition | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) |
| Short | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) |
| Control | 1..1 |
| Type | Ratio |
| 1008. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Strength-Concentration | |
| Definition | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) |
| Short | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) |
| Control | 0..1 |
| Type | Ratio |
| 1010. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.MeasurementPoint | |
| Definition | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) |
| Short | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1012. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Country | |
| Definition | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) |
| Short | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) |
| Control | 0..* |
| Type | CodeableConcept |
| 1014. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength | |
| Definition | 9.7.2.6 |
| Short | 9.7.2.6 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1016. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1018. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1020. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1022. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSubstance | |
| Definition | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) |
| Short | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1024. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance | |
| Definition | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) |
| Short | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1026. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrength | |
| Definition | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) |
| Short | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) |
| Control | 1..1 |
| Type | Ratio |
| 1028. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint | |
| Definition | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) |
| Short | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1030. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthCountry | |
| Definition | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) |
| Short | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) |
| Control | 0..* |
| Type | CodeableConcept |
| 1032. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance | |
| Definition | 9.7.2.3 |
| Short | 9.7.2.3 |
| Control | 0..1 |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1034. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1036. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1038. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1040. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Substance | |
| Definition | A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2) |
| Short | A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1042. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength | |
| Definition | 9.7.2.5 |
| Short | 9.7.2.5 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1044. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1046. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1048. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1050. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.Strength-Presentation | |
| Definition | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) |
| Short | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) |
| Control | 1..1 |
| Type | Ratio |
| 1052. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.Strength-Concentration | |
| Definition | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) |
| Short | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) |
| Control | 0..1 |
| Type | Ratio |
| 1054. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.MeasurementPoint | |
| Definition | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) |
| Short | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1056. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.Country | |
| Definition | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) |
| Short | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) |
| Control | 0..* |
| Type | CodeableConcept |
| 1058. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength | |
| Definition | 9.7.2.6 |
| Short | 9.7.2.6 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1060. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1062. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1064. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1066. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSubstance | |
| Definition | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) |
| Short | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1068. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance | |
| Definition | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) |
| Short | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1070. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrength | |
| Definition | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) |
| Short | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) |
| Control | 1..1 |
| Type | Ratio |
| 1072. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint | |
| Definition | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) |
| Short | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1074. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthCountry | |
| Definition | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) |
| Short | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) |
| Control | 0..* |
| Type | CodeableConcept |
| 1076. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation | |
| Definition | 9.5.2.2 |
| Short | 9.5.2.2 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1078. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1080. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1082. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1084. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 1086. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1088. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 1090. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1092. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1094. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1096. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1098. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1100. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1102. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 1104. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 1106. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1108. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1110. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1112. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1114. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1116. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1118. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1120. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 1122. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1124. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 1126. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1128. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation | |
| Definition | 9.5.2.3 |
| Short | 9.5.2.3 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1130. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1132. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1134. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1136. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType | |
| Definition | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Short | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1138. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber | |
| Definition | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Short | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Control | 0..1 |
| Type | Identifier |
| 1140. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate | |
| Definition | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Short | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Control | 0..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1142. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator | |
| Definition | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Short | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1144. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation | |
| Definition | 9.3.2.5 |
| Short | 9.3.2.5 |
| Control | 0..1 |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1146. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1148. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1150. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1152. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 1154. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1156. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 1158. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1160. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1162. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1164. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1166. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1168. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1170. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 1172. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 1174. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1176. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1178. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1180. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1182. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1184. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1186. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1188. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 1190. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1192. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 1194. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1196. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics | |
| Definition | 9.6.2.22 |
| Short | 9.6.2.22 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1198. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1200. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.OtherCharacteristics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1202. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1204. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics.CodeSystem | |
| Definition | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) |
| Short | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1206. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics.Value | |
| Definition | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) |
| Short | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1208. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics | |
| Definition | 11.13 |
| Short | 11.13 |
| Control | 0..1 |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1210. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1212. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1214. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1216. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Height | |
| Definition | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) |
| Short | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) |
| Control | 0..1 |
| Type | Quantity |
| 1218. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Width | |
| Definition | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) |
| Short | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) |
| Control | 0..1 |
| Type | Quantity |
| 1220. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Depth | |
| Definition | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) |
| Short | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) |
| Control | 0..1 |
| Type | Quantity |
| 1222. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Weight | |
| Definition | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) |
| Short | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) |
| Control | 0..1 |
| Type | Quantity |
| 1224. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.NominalVolume | |
| Definition | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) |
| Short | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) |
| Control | 0..1 |
| Type | Quantity |
| 1226. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.ExternalDiameter | |
| Definition | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) |
| Short | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) |
| Control | 0..1 |
| Type | Quantity |
| 1228. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Shape | |
| Definition | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) |
| Short | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1230. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Colour | |
| Definition | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) |
| Short | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1232. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Imprint | |
| Definition | Where applicable, the imprint can be specified as text. (9.6.2.21.10) |
| Short | Where applicable, the imprint can be specified as text. (9.6.2.21.10) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1234. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Image | |
| Definition | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) |
| Short | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) |
| Control | 0..* |
| Type | base64Binary |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1236. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Scoring | |
| Definition | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) |
| Short | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1238. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation | |
| Definition | 9.5.2.2 |
| Short | 9.5.2.2 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1240. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1242. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1244. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1246. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 1248. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1250. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 1252. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1254. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1256. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1258. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1260. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1262. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1264. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 1266. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 1268. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1270. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1272. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1274. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1276. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1278. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1280. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1282. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 1284. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1286. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 1288. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1290. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation | |
| Definition | 9.5.2.3 |
| Short | 9.5.2.3 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1292. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1294. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1296. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1298. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType | |
| Definition | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Short | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1300. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber | |
| Definition | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Short | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Control | 0..1 |
| Type | Identifier |
| 1302. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate | |
| Definition | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Short | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Control | 0..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1304. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator | |
| Definition | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Short | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1306. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation | |
| Definition | 9.3.2.5 |
| Short | 9.3.2.5 |
| Control | 0..1 |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1308. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1310. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1312. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1314. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 1316. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1318. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 1320. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1322. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1324. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1326. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1328. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1330. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1332. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 1334. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 1336. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1338. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1340. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1342. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1344. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1346. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1348. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1350. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 1352. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1354. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 1356. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1358. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics | |
| Definition | 9.6.2.22 |
| Short | 9.6.2.22 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1360. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1362. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.OtherCharacteristics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1364. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1366. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics.CodeSystem | |
| Definition | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) |
| Short | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1368. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics.Value | |
| Definition | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) |
| Short | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1370. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component | |
| Definition | 9.6.2.9 |
| Short | 9.6.2.9 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1372. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1374. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Package_Component.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1376. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1378. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.ComponentType | |
| Definition | The type of component whose material is being described may be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.9.2) |
| Short | The type of component whose material is being described may be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.9.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1380. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.ComponentMaterial | |
| Definition | The material(s) of the component can be specified. Materials may be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. (9.6.2.9.3) |
| Short | The material(s) of the component can be specified. Materials may be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. (9.6.2.9.3) |
| Control | 0..* |
| Type | CodeableConcept |
| 1382. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.ComponentAlternateMaterial | |
| Definition | Alternative materials for the component can be specified. Materials shall be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of rubber for a stopper). (9.6.2.9.4) |
| Short | Alternative materials for the component can be specified. Materials shall be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of rubber for a stopper). (9.6.2.9.4) |
| Control | 0..* |
| Type | CodeableConcept |
| 1384. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation | |
| Definition | 9.5.2.2 |
| Short | 9.5.2.2 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1386. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1388. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1390. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1392. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 1394. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1396. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 1398. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1400. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1402. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1404. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1406. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1408. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1410. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 1412. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 1414. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1416. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1418. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1420. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1422. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1424. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1426. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1428. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 1430. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1432. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 1434. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1436. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation | |
| Definition | 9.5.2.3 |
| Short | 9.5.2.3 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1438. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1440. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1442. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1444. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType | |
| Definition | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Short | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1446. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber | |
| Definition | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Short | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Control | 0..1 |
| Type | Identifier |
| 1448. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate | |
| Definition | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Short | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Control | 0..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1450. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator | |
| Definition | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Short | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1452. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation | |
| Definition | 9.3.2.5 |
| Short | 9.3.2.5 |
| Control | 0..1 |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1454. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1456. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1458. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1460. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 1462. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1464. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 1466. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1468. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1470. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1472. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1474. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1476. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1478. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 1480. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 1482. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1484. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1486. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1488. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1490. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1492. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1494. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1496. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 1498. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1500. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 1502. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1504. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics | |
| Definition | 11.13 |
| Short | 11.13 |
| Control | 0..1 |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1506. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1508. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1510. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1512. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Height | |
| Definition | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) |
| Short | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) |
| Control | 0..1 |
| Type | Quantity |
| 1514. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Width | |
| Definition | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) |
| Short | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) |
| Control | 0..1 |
| Type | Quantity |
| 1516. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Depth | |
| Definition | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) |
| Short | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) |
| Control | 0..1 |
| Type | Quantity |
| 1518. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Weight | |
| Definition | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) |
| Short | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) |
| Control | 0..1 |
| Type | Quantity |
| 1520. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.NominalVolume | |
| Definition | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) |
| Short | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) |
| Control | 0..1 |
| Type | Quantity |
| 1522. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.ExternalDiameter | |
| Definition | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) |
| Short | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) |
| Control | 0..1 |
| Type | Quantity |
| 1524. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Shape | |
| Definition | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) |
| Short | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1526. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Colour | |
| Definition | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) |
| Short | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1528. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Imprint | |
| Definition | Where applicable, the imprint can be specified as text. (9.6.2.21.10) |
| Short | Where applicable, the imprint can be specified as text. (9.6.2.21.10) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1530. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Image | |
| Definition | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) |
| Short | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) |
| Control | 0..* |
| Type | base64Binary |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1532. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Scoring | |
| Definition | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) |
| Short | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1534. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics | |
| Definition | 11.13 |
| Short | 11.13 |
| Control | 0..1 |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1536. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1538. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1540. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1542. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Height | |
| Definition | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) |
| Short | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) |
| Control | 0..1 |
| Type | Quantity |
| 1544. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Width | |
| Definition | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) |
| Short | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) |
| Control | 0..1 |
| Type | Quantity |
| 1546. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Depth | |
| Definition | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) |
| Short | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) |
| Control | 0..1 |
| Type | Quantity |
| 1548. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Weight | |
| Definition | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) |
| Short | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) |
| Control | 0..1 |
| Type | Quantity |
| 1550. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.NominalVolume | |
| Definition | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) |
| Short | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) |
| Control | 0..1 |
| Type | Quantity |
| 1552. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.ExternalDiameter | |
| Definition | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) |
| Short | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) |
| Control | 0..1 |
| Type | Quantity |
| 1554. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Shape | |
| Definition | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) |
| Short | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1556. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Colour | |
| Definition | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) |
| Short | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1558. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Imprint | |
| Definition | Where applicable, the imprint can be specified as text. (9.6.2.21.10) |
| Short | Where applicable, the imprint can be specified as text. (9.6.2.21.10) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1560. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Image | |
| Definition | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) |
| Short | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) |
| Control | 0..* |
| Type | base64Binary |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1562. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Scoring | |
| Definition | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) |
| Short | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1564. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage | |
| Definition | 9.6.2.11 |
| Short | 9.6.2.11 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1566. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1568. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem_Container.ShelfLife-Storage.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1570. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1572. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.ShelfLifeType | |
| Definition | This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2) |
| Short | This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1574. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.ShelfLifeTimePeriod | |
| Definition | The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3) |
| Short | The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3) |
| Control | 1..1 |
| Type | Quantity |
| 1576. InvestigationalMedicinalProduct.InvestigationalPackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.SpecialPrecautionsForStorage | |
| Definition | Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4) |
| Short | Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4) |
| Control | 0..* |
| Type | CodeableConcept |
| 1578. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation | |
| Definition | 9.5.2.2 |
| Short | 9.5.2.2 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1580. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1582. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.Manufacturer-Establishment_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1584. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1586. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 1588. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1590. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 1592. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1594. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1596. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1598. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1600. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.Manufacturer-Establishment_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1602. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1604. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 1606. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 1608. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1610. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1612. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1614. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1616. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1618. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1620. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1622. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 1624. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1626. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 1628. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1630. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation | |
| Definition | 9.5.2.3 |
| Short | 9.5.2.3 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1632. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1634. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1636. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1638. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType | |
| Definition | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Short | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1640. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber | |
| Definition | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Short | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Control | 0..1 |
| Type | Identifier |
| 1642. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate | |
| Definition | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Short | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Control | 0..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1644. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator | |
| Definition | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Short | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1646. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation | |
| Definition | 9.3.2.5 |
| Short | 9.3.2.5 |
| Control | 0..1 |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1648. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1650. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1652. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1654. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 1656. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1658. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 1660. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1662. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1664. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1666. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1668. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1670. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1672. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 1674. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 1676. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1678. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1680. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1682. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1684. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1686. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1688. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1690. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 1692. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1694. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 1696. InvestigationalMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1698. InvestigationalMedicinalProduct.OrphanDesignation | |
| Definition | 9.2.2.3 |
| Short | 9.2.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1700. InvestigationalMedicinalProduct.OrphanDesignation.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1702. InvestigationalMedicinalProduct.OrphanDesignation.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.OrphanDesignation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1704. InvestigationalMedicinalProduct.OrphanDesignation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1706. InvestigationalMedicinalProduct.OrphanDesignation.OrphanIndicationType | |
| Definition | This attribute is for the type of intended use of the Medicinal Product, for instance disease prevention, treatment or diagnostic. (9.2.2.3.2) |
| Short | This attribute is for the type of intended use of the Medicinal Product, for instance disease prevention, treatment or diagnostic. (9.2.2.3.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1708. InvestigationalMedicinalProduct.OrphanDesignation.OrphanProcedureNumber | |
| Definition | This attribute is the procedure number for the orphan designation authorisation application. (9.2.2.3.3) |
| Short | This attribute is the procedure number for the orphan designation authorisation application. (9.2.2.3.3) |
| Control | 0..1 |
| Type | Identifier |
| 1710. InvestigationalMedicinalProduct.OrphanDesignation.OrphanDesignationAuthorisationStatus | |
| Definition | This attribute is for describing the status of the orphan designation authorisation, for instance granted, pending, expired or withdrawn. (9.2.2.3.4) |
| Short | This attribute is for describing the status of the orphan designation authorisation, for instance granted, pending, expired or withdrawn. (9.2.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1712. InvestigationalMedicinalProduct.OrphanDesignation.OrphanDesignationAuthorisationDate | |
| Definition | This attribute is for the date in which the orphan designation status was granted. (9.2.2.3.5) |
| Short | This attribute is for the date in which the orphan designation status was granted. (9.2.2.3.5) |
| Control | 0..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1714. InvestigationalMedicinalProduct.OrphanDesignation.OrphanDesignationNumber | |
| Definition | This field is to indicate the orphan designation decision number. (9.2.2.3.6) |
| Short | This field is to indicate the orphan designation decision number. (9.2.2.3.6) |
| Control | 0..1 |
| Type | Identifier |
| 1716. InvestigationalMedicinalProduct.PharmaceuticalProduct | |
| Definition | 11.7.2 |
| Short | 11.7.2 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1718. InvestigationalMedicinalProduct.PharmaceuticalProduct.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1720. InvestigationalMedicinalProduct.PharmaceuticalProduct.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1722. InvestigationalMedicinalProduct.PharmaceuticalProduct.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1724. InvestigationalMedicinalProduct.PharmaceuticalProduct.AdministrableDoseForm | |
| Definition | This shall describe the administrable dose form in accordance with the regulated product information. This is after it has undergone any necessary reconstitution, where applicable. The administrable dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and the resulting terminology. The term and the term identifier shall be specified. In certain instances, the administrable dose form differs from the manufactured dose form when a transformation of the manufactured dose form has been carried out. The manufactured dose forms of two manufactured items are described as “powder for solution for injection” and “solvent for solution for injection” which after transformation correspond to the administrable dose form “solution for injection”. (9.8.2.2.2) |
| Short | This shall describe the administrable dose form in accordance with the regulated product information. This is after it has undergone any necessary reconstitution, where applicable. The administrable dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and the resulting terminology. The term and the term identifier shall be specified. In certain instances, the administrable dose form differs from the manufactured dose form when a transformation of the manufactured dose form has been carried out. The manufactured dose forms of two manufactured items are described as “powder for solution for injection” and “solvent for solution for injection” which after transformation correspond to the administrable dose form “solution for injection”. (9.8.2.2.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1726. InvestigationalMedicinalProduct.PharmaceuticalProduct.UnitOfPresentation | |
| Definition | The unit of presentation is a qualitative term describing the discrete unit in which a pharmaceutical product is presented to describe strength or quantity in cases where a quantitative unit of measurement is not appropriate. It is a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. For pharmaceutical products whose strength is measured as a quantity of weight or volume, the “unit of presentation” can be specified as the immediate (lowest level) container. For solid dose forms and other items whose strength is described on the basis of the amount in the unit of presentation, and which are counted in integer quantities, the unit for quantity shall be “1 unit” and the unit of presentation shall be the item that is counted, specified as a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. (9.8.2.2.3) |
| Short | The unit of presentation is a qualitative term describing the discrete unit in which a pharmaceutical product is presented to describe strength or quantity in cases where a quantitative unit of measurement is not appropriate. It is a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. For pharmaceutical products whose strength is measured as a quantity of weight or volume, the “unit of presentation” can be specified as the immediate (lowest level) container. For solid dose forms and other items whose strength is described on the basis of the amount in the unit of presentation, and which are counted in integer quantities, the unit for quantity shall be “1 unit” and the unit of presentation shall be the item that is counted, specified as a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. (9.8.2.2.3) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1728. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device | |
| Definition | 9.6.2.12 |
| Short | 9.6.2.12 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1730. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1732. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1734. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1736. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceType | |
| Definition | The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2) |
| Short | The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1738. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceTradeName | |
| Definition | This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3) |
| Short | This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1740. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceQuantity | |
| Definition | The quantity of the device present in the pack shall be specified. (9.6.2.12.4) |
| Short | The quantity of the device present in the pack shall be specified. (9.6.2.12.4) |
| Control | 1..1 |
| Type | Quantity |
| 1742. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceListingNumber | |
| Definition | This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5) |
| Short | This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1744. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceIdentifier | |
| Definition | A unique device identifier needs to be specified. (9.6.2.12.6) |
| Short | A unique device identifier needs to be specified. (9.6.2.12.6) |
| Control | 0..1 |
| Type | Identifier |
| 1746. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.ModelNumber | |
| Definition | This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7) |
| Short | This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1748. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.SterilityIndicator | |
| Definition | Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8) |
| Short | Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1750. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.SterilisationRequirementIndicator | |
| Definition | Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9) |
| Short | Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1752. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceUsage | |
| Definition | The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10) |
| Short | The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1754. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier | |
| Definition | 11.12 |
| Short | 11.12 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1756. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1758. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1760. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1762. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.BatchNumber | |
| Definition | Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2) |
| Short | Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1764. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.ExpirationDate | |
| Definition | Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3) |
| Short | Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3) |
| Control | 1..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1766. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial | |
| Definition | 9.6.2.13 |
| Short | 9.6.2.13 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1768. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1770. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1772. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1774. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.Substance | |
| Definition | The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2) |
| Short | The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1776. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.Alternate | |
| Definition | This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3) |
| Short | This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3) |
| Control | 0..1 |
| Type | Element(BL) |
| 1778. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.AllergenicIndicator | |
| Definition | This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4) |
| Short | This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4) |
| Control | 0..1 |
| Type | Element(BL) |
| 1780. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature | |
| Definition | 11.11 |
| Short | 11.11 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1782. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1784. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1786. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1788. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.CodeSystem | |
| Definition | The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2) |
| Short | The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1790. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.Value | |
| Definition | The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3) |
| Short | The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1792. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation | |
| Definition | 9.5.2.2 |
| Short | 9.5.2.2 |
| Control | 0..1 |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1794. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1796. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1798. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1800. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 1802. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1804. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 1806. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1808. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1810. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1812. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1814. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1816. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1818. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 1820. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 1822. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1824. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1826. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1828. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1830. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1832. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1834. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1836. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 1838. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1840. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 1842. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1844. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation | |
| Definition | 9.5.2.3 |
| Short | 9.5.2.3 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1846. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1848. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1850. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1852. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType | |
| Definition | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Short | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1854. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber | |
| Definition | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Short | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Control | 0..1 |
| Type | Identifier |
| 1856. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate | |
| Definition | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Short | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Control | 0..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1858. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator | |
| Definition | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Short | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1860. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation | |
| Definition | 9.3.2.5 |
| Short | 9.3.2.5 |
| Control | 0..1 |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1862. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1864. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1866. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1868. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 1870. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1872. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 1874. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1876. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1878. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1880. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1882. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1884. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1886. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 1888. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 1890. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1892. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1894. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1896. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1898. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1900. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1902. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1904. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 1906. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1908. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 1910. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1912. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics | |
| Definition | 9.6.2.22 |
| Short | 9.6.2.22 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1914. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1916. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1918. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1920. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.CodeSystem | |
| Definition | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) |
| Short | The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1922. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.Value | |
| Definition | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) |
| Short | The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1924. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics | |
| Definition | 11.13 |
| Short | 11.13 |
| Control | 0..1 |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1926. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1928. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1930. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1932. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Height | |
| Definition | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) |
| Short | Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2) |
| Control | 0..1 |
| Type | Quantity |
| 1934. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Width | |
| Definition | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) |
| Short | Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3) |
| Control | 0..1 |
| Type | Quantity |
| 1936. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Depth | |
| Definition | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) |
| Short | Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4) |
| Control | 0..1 |
| Type | Quantity |
| 1938. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Weight | |
| Definition | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) |
| Short | Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5) |
| Control | 0..1 |
| Type | Quantity |
| 1940. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.NominalVolume | |
| Definition | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) |
| Short | Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6) |
| Control | 0..1 |
| Type | Quantity |
| 1942. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.ExternalDiameter | |
| Definition | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) |
| Short | Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7) |
| Control | 0..1 |
| Type | Quantity |
| 1944. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Shape | |
| Definition | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) |
| Short | Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1946. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Colour | |
| Definition | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) |
| Short | Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1948. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Imprint | |
| Definition | Where applicable, the imprint can be specified as text. (9.6.2.21.10) |
| Short | Where applicable, the imprint can be specified as text. (9.6.2.21.10) |
| Control | 0..* |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1950. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Image | |
| Definition | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) |
| Short | Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11) |
| Control | 0..* |
| Type | base64Binary |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 1952. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Scoring | |
| Definition | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) |
| Short | Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12) |
| Control | 0..1 |
| Type | CodeableConcept |
| 1954. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage | |
| Definition | 9.6.2.11 |
| Short | 9.6.2.11 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1956. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1958. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1960. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1962. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.ShelfLifeType | |
| Definition | This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2) |
| Short | This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1964. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.ShelfLifeTimePeriod | |
| Definition | The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3) |
| Short | The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3) |
| Control | 1..1 |
| Type | Quantity |
| 1966. InvestigationalMedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.SpecialPrecautionsForStorage | |
| Definition | Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4) |
| Short | Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4) |
| Control | 0..* |
| Type | CodeableConcept |
| 1968. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration | |
| Definition | 11.7.3 |
| Short | 11.7.3 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1970. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1972. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1974. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1976. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration.RouteOfAdministration | |
| Definition | (11.7.3.0) |
| Short | (11.7.3.0) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1978. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration.FirstDoseInHumans | |
| Definition | The first dose (dose quantity) administered in humans can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and symbol identifier shall be used. (11.7.3.2) |
| Short | The first dose (dose quantity) administered in humans can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and symbol identifier shall be used. (11.7.3.2) |
| Control | 0..1 |
| Type | Quantity |
| 1980. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration.MaximumSingleDose | |
| Definition | The maximum single dose (maximum single dose quantity) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.3) |
| Short | The maximum single dose (maximum single dose quantity) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.3) |
| Control | 0..1 |
| Type | Quantity |
| 1982. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration.MaximumDosePerDay | |
| Definition | The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.4) |
| Short | The maximum dose per day (maximum dose quantity to be administered in any one 24-h period) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.4) |
| Control | 0..1 |
| Type | Quantity |
| 1984. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration.MaximumDosePerTreatmentPeriod | |
| Definition | The maximum dose per treatment period (maximum total dose quantity to be administered in the treatment period) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.5) |
| Short | The maximum dose per treatment period (maximum total dose quantity to be administered in the treatment period) that can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.5) |
| Control | 0..1 |
| Type | Ratio |
| 1986. InvestigationalMedicinalProduct.PharmaceuticalProduct.DosingAndRouteOfAdministration.MaximumTreatmentPeriod | |
| Definition | The maximum treatment period during which the Investigational Medicinal Product can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of time measurement. The unit of time measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.6) |
| Short | The maximum treatment period during which the Investigational Medicinal Product can be administered as per the protocol referenced in the clinical trial authorisation can be specified using a numerical value and its unit of time measurement. The unit of time measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (11.7.3.6) |
| Control | 0..1 |
| Type | Quantity |
| 1988. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient | |
| Definition | 11.2.9 |
| Short | 11.2.9 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 1990. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 1992. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 1994. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 1996. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.IngredientRole | |
| Definition | The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2) |
| Short | The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 1998. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.AllergenicIndicator | |
| Definition | This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3) |
| Short | This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3) |
| Control | 0..1 |
| Type | Element(BL) |
| 2000. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation | |
| Definition | 9.5.2.2 |
| Short | 9.5.2.2 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 2002. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 2004. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 2006. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 2008. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 2010. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 2012. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 2014. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 2016. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 2018. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 2020. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 2022. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 2024. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 2026. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 2028. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 2030. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 2032. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 2034. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 2036. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 2038. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 2040. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 2042. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 2044. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 2046. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 2048. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 2050. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 2052. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation | |
| Definition | 9.5.2.3 |
| Short | 9.5.2.3 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 2054. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 2056. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 2058. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 2060. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType | |
| Definition | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Short | The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 2062. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber | |
| Definition | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Short | The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3) |
| Control | 0..1 |
| Type | Identifier |
| 2064. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate | |
| Definition | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Short | The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4) |
| Control | 0..1 |
| Type | date |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 2066. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator | |
| Definition | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Short | The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 2068. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation | |
| Definition | 9.3.2.5 |
| Short | 9.3.2.5 |
| Control | 0..1 |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 2070. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 2072. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 2074. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 2076. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier | |
| Definition | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Short | The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2) |
| Control | 1..1 |
| Type | Identifier |
| 2078. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name | |
| Definition | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Short | The name of the organisation shall be provided in text. (9.4.2.2.3) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 2080. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address | |
| Definition | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Short | The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4) |
| Control | 1..1 |
| Type | Address |
| 2082. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator | |
| Definition | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Short | The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 2084. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 2086. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact | |
| Definition | 9.4.2.4 |
| Short | 9.4.2.4 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 2088. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 2090. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 2092. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 2094. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name | |
| Definition | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Short | The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2) |
| Control | 0..1 |
| Type | HumanName |
| 2096. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom | |
| Definition | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Short | The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3) |
| Control | 1..* |
| Type | ContactPoint |
| 2098. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role | |
| Definition | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Short | The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 2100. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator | |
| Definition | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Short | The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 2102. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations | |
| Definition | 9.4.2.3 |
| Short | 9.4.2.3 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 2104. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 2106. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 2108. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 2110. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName | |
| Definition | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Short | This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 2112. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress | |
| Definition | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Short | The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3) |
| Control | 1..1 |
| Type | Address |
| 2114. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole | |
| Definition | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Short | The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4) |
| Control | 1..1 |
| Type | CodeableConcept |
| 2116. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier | |
| Definition | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Short | The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5) |
| Control | 0..1 |
| Type | Identifier |
| 2118. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates | |
| Definition | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Short | These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 2120. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance | |
| Definition | 9.7.2.4 |
| Short | 9.7.2.4 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 2122. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 2124. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 2126. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 2128. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.SpecifiedSubstance | |
| Definition | When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2) |
| Short | When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 2130. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.SpecifiedSubstanceGroup | |
| Definition | The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3) |
| Short | The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3) |
| Control | 1..1 |
| Type | CodeableConcept |
| 2132. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.ConfidentialityIndicator | |
| Definition | The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4) |
| Short | The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4) |
| Control | 0..1 |
| Type | CodeableConcept |
| 2134. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength | |
| Definition | 9.7.2.5 |
| Short | 9.7.2.5 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 2136. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 2138. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 2140. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 2142. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Strength-Presentation | |
| Definition | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) |
| Short | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) |
| Control | 1..1 |
| Type | Ratio |
| 2144. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Strength-Concentration | |
| Definition | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) |
| Short | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) |
| Control | 0..1 |
| Type | Ratio |
| 2146. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.MeasurementPoint | |
| Definition | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) |
| Short | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 2148. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Country | |
| Definition | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) |
| Short | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) |
| Control | 0..* |
| Type | CodeableConcept |
| 2150. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength | |
| Definition | 9.7.2.6 |
| Short | 9.7.2.6 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 2152. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 2154. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 2156. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 2158. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSubstance | |
| Definition | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) |
| Short | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) |
| Control | 0..1 |
| Type | CodeableConcept |
| 2160. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance | |
| Definition | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) |
| Short | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) |
| Control | 0..1 |
| Type | CodeableConcept |
| 2162. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrength | |
| Definition | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) |
| Short | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) |
| Control | 1..1 |
| Type | Ratio |
| 2164. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint | |
| Definition | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) |
| Short | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 2166. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthCountry | |
| Definition | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) |
| Short | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) |
| Control | 0..* |
| Type | CodeableConcept |
| 2168. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance | |
| Definition | 9.7.2.3 |
| Short | 9.7.2.3 |
| Control | 0..1 |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 2170. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 2172. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 2174. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 2176. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Substance | |
| Definition | A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2) |
| Short | A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 2178. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength | |
| Definition | 9.7.2.5 |
| Short | 9.7.2.5 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 2180. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 2182. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 2184. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 2186. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Strength-Presentation | |
| Definition | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) |
| Short | The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2) |
| Control | 1..1 |
| Type | Ratio |
| 2188. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Strength-Concentration | |
| Definition | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) |
| Short | The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3) |
| Control | 0..1 |
| Type | Ratio |
| 2190. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.MeasurementPoint | |
| Definition | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) |
| Short | There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 2192. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Country | |
| Definition | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) |
| Short | The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5) |
| Control | 0..* |
| Type | CodeableConcept |
| 2194. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength | |
| Definition | 9.7.2.6 |
| Short | 9.7.2.6 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 2196. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 2198. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 2200. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 2202. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSubstance | |
| Definition | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) |
| Short | If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2) |
| Control | 0..1 |
| Type | CodeableConcept |
| 2204. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance | |
| Definition | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) |
| Short | If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3) |
| Control | 0..1 |
| Type | CodeableConcept |
| 2206. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrength | |
| Definition | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) |
| Short | The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4) |
| Control | 1..1 |
| Type | Ratio |
| 2208. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint | |
| Definition | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) |
| Short | The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5) |
| Control | 0..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 2210. InvestigationalMedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthCountry | |
| Definition | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) |
| Short | Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6) |
| Control | 0..* |
| Type | CodeableConcept |
| 2212. InvestigationalMedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics | |
| Definition | 9.8.2.4 |
| Short | 9.8.2.4 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 2214. InvestigationalMedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 2216. InvestigationalMedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 2218. InvestigationalMedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 2220. InvestigationalMedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.CodeSystem | |
| Definition | The code system being used to describe the type of characteristic shall be specified using an appropriate identification system. (9.8.2.4.2) |
| Short | The code system being used to describe the type of characteristic shall be specified using an appropriate identification system. (9.8.2.4.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 2222. InvestigationalMedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.Value | |
| Definition | The individual value from the code system that describes the actual characteristic shall be specified using a controlled term and a controlled term identifier. (9.8.2.4.3) |
| Short | The individual value from the code system that describes the actual characteristic shall be specified using a controlled term and a controlled term identifier. (9.8.2.4.3) |
| Control | 1..1 |
| Type | CodeableConcept |
| 2224. InvestigationalMedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.Status | |
| Definition | The status of the pharmaceutical product characteristic should be listed here, e.g. assigned, not assigned or pending. (9.8.2.4.4) |
| Short | The status of the pharmaceutical product characteristic should be listed here, e.g. assigned, not assigned or pending. (9.8.2.4.4) |
| Control | 0..1 |
| Type | CodeableConcept |
| 2226. InvestigationalMedicinalProduct.PharmaceuticalProduct.PhPIDSet | |
| Definition | 9.8.2.6 |
| Short | 9.8.2.6 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 2228. InvestigationalMedicinalProduct.PharmaceuticalProduct.PhPIDSet.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 2230. InvestigationalMedicinalProduct.PharmaceuticalProduct.PhPIDSet.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.PharmaceuticalProduct.PhPIDSet.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 2232. InvestigationalMedicinalProduct.PharmaceuticalProduct.PhPIDSet.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 2234. InvestigationalMedicinalProduct.PharmaceuticalProduct.PhPIDSet.PhPIDIdentifierSets | |
| Definition | This class shall carry the relevant identifiers as defined by ISO 11616 and ISO / TS 20451 . This provides a uniform representation of the pharmaceutical product using the substance(s)/specified substance(s), their (reference) strength(s), the administrable dose form and, where applicable, the integral device. (9.8.2.6.0) |
| Short | This class shall carry the relevant identifiers as defined by ISO 11616 and ISO / TS 20451 . This provides a uniform representation of the pharmaceutical product using the substance(s)/specified substance(s), their (reference) strength(s), the administrable dose form and, where applicable, the integral device. (9.8.2.6.0) |
| Control | 1..1 |
| Type | Identifier |
| 2236. InvestigationalMedicinalProduct.ProductClassification | |
| Definition | 11.3.2.7 |
| Short | 11.3.2.7 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 2238. InvestigationalMedicinalProduct.ProductClassification.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 2240. InvestigationalMedicinalProduct.ProductClassification.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.ProductClassification.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 2242. InvestigationalMedicinalProduct.ProductClassification.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 2244. InvestigationalMedicinalProduct.ProductClassification.CodeSystem | |
| Definition | The Medicinal Product can be classified according to various classification systems, which may be regional, jurisdictional or international. The various classifications of the product can be specified in this subclause. The classification system shall be specified using an appropriate identification system; the controlled term and the controlled term identifier shall be specified. (9.2.2.4.2) |
| Short | The Medicinal Product can be classified according to various classification systems, which may be regional, jurisdictional or international. The various classifications of the product can be specified in this subclause. The classification system shall be specified using an appropriate identification system; the controlled term and the controlled term identifier shall be specified. (9.2.2.4.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 2246. InvestigationalMedicinalProduct.ProductClassification.Value | |
| Definition | The individual value from the classification system that applies to the Medicinal Product shall be specified using a controlled term and a controlled term identifier. (9.2.2.4.3) |
| Short | The individual value from the classification system that applies to the Medicinal Product shall be specified using a controlled term and a controlled term identifier. (9.2.2.4.3) |
| Control | 1..1 |
| Type | CodeableConcept |
| 2248. InvestigationalMedicinalProduct.ProductCross-Reference | |
| Definition | 11.3.2.4 |
| Short | 11.3.2.4 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 2250. InvestigationalMedicinalProduct.ProductCross-Reference.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 2252. InvestigationalMedicinalProduct.ProductCross-Reference.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.ProductCross-Reference.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 2254. InvestigationalMedicinalProduct.ProductCross-Reference.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 2256. InvestigationalMedicinalProduct.ProductCross-Reference.I-MPIDCross-Reference | |
| Definition | This is an attribute used to reference other IMPID(s) or MPID(s) related to the medicinal. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.2) |
| Short | This is an attribute used to reference other IMPID(s) or MPID(s) related to the medicinal. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.2) |
| Control | 1..1 |
| Type | Identifier |
| 2258. InvestigationalMedicinalProduct.ProductCross-Reference.ReferencedProductType | |
| Definition | This attribute is to identify which kind of Medicinal Product is cross-referenced. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.3) |
| Short | This attribute is to identify which kind of Medicinal Product is cross-referenced. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.3) |
| Control | 0..1 |
| Type | CodeableConcept |
| 2260. InvestigationalMedicinalProduct.TherapeuticIndication | |
| Definition | 9.9.2.2 |
| Short | 9.9.2.2 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 2262. InvestigationalMedicinalProduct.TherapeuticIndication.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 2264. InvestigationalMedicinalProduct.TherapeuticIndication.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.TherapeuticIndication.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 2266. InvestigationalMedicinalProduct.TherapeuticIndication.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 2268. InvestigationalMedicinalProduct.TherapeuticIndication.IndicationText | |
| Definition | The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2) |
| Short | The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 2270. InvestigationalMedicinalProduct.TherapeuticIndication.IndicationAsDisease-Symptom-Procedure | |
| Definition | The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3) |
| Short | The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3) |
| Control | 0..1 |
| Type | CodeableConcept |
| 2272. InvestigationalMedicinalProduct.TherapeuticIndication.DiseaseStatus | |
| Definition | The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4) |
| Short | The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4) |
| Control | 0..1 |
| Type | CodeableConcept |
| 2274. InvestigationalMedicinalProduct.TherapeuticIndication.Comorbidity | |
| Definition | If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5) |
| Short | If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5) |
| Control | 0..* |
| Type | CodeableConcept |
| 2276. InvestigationalMedicinalProduct.TherapeuticIndication.IntendedEffect | |
| Definition | The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6) |
| Short | The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6) |
| Control | 0..1 |
| Type | CodeableConcept |
| 2278. InvestigationalMedicinalProduct.TherapeuticIndication.Timing-Duration | |
| Definition | If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7) |
| Short | If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7) |
| Control | 0..1 |
| Type | Quantity |
| 2280. InvestigationalMedicinalProduct.TherapeuticIndication.OtherTherapySpecifics | |
| Definition | 9.9.2.6 |
| Short | 9.9.2.6 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 2282. InvestigationalMedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 2284. InvestigationalMedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 2286. InvestigationalMedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 2288. InvestigationalMedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.TherapyRelationshipType | |
| Definition | The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2) |
| Short | The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2) |
| Control | 1..1 |
| Type | CodeableConcept |
| 2290. InvestigationalMedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.Medication | |
| Definition | Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3) |
| Short | Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3) |
| Control | 1..1 |
| Type | CodeableConcept |
| 2292. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics | |
| Definition | 9.9.2.5 |
| Short | 9.9.2.5 |
| Control | 1..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 2294. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 2296. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 2298. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 2300. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics.Age | |
| Definition | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) |
| Short | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) |
| Control | 0..1 |
| Type | CodeableConcept |
| 2302. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics.AgeRangeLow | |
| Definition | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) |
| Short | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) |
| Control | 0..1 |
| Type | Quantity |
| 2304. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics.AgeRangeHigh | |
| Definition | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) |
| Short | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) |
| Control | 0..1 |
| Type | Quantity |
| 2306. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics.Gender | |
| Definition | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) |
| Short | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 2308. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics.Race | |
| Definition | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) |
| Short | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) |
| Control | 0..1 |
| Type | CodeableConcept |
| 2310. InvestigationalMedicinalProduct.TherapeuticIndication.PopulationSpecifics.PhysiologicalCondition | |
| Definition | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) |
| Short | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) |
| Control | 0..1 |
| Type | CodeableConcept |
| 2312. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects | |
| Definition | 9.9.2.4 |
| Short | 9.9.2.4 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 2314. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 2316. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 2318. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 2320. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.UndesirableEffectText | |
| Definition | The text of the undesirable effect shall be given. (9.9.2.4.2) |
| Short | The text of the undesirable effect shall be given. (9.9.2.4.2) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 2322. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.UndesirableEffectAsSymptom-Condition-Effect | |
| Definition | The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3) |
| Short | The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3) |
| Control | 0..1 |
| Type | CodeableConcept |
| 2324. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.Symptom-Condition-EffectClassification | |
| Definition | The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4) |
| Short | The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4) |
| Control | 0..1 |
| Type | CodeableConcept |
| 2326. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.FrequencyOfOccurrence | |
| Definition | The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5) |
| Short | The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 2328. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics | |
| Definition | 9.9.2.5 |
| Short | 9.9.2.5 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 2330. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 2332. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 2334. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 2336. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Age | |
| Definition | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) |
| Short | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) |
| Control | 0..1 |
| Type | CodeableConcept |
| 2338. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeLow | |
| Definition | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) |
| Short | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) |
| Control | 0..1 |
| Type | Quantity |
| 2340. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeHigh | |
| Definition | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) |
| Short | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) |
| Control | 0..1 |
| Type | Quantity |
| 2342. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Gender | |
| Definition | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) |
| Short | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 2344. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Race | |
| Definition | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) |
| Short | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) |
| Control | 0..1 |
| Type | CodeableConcept |
| 2346. InvestigationalMedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.PhysiologicalCondition | |
| Definition | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) |
| Short | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) |
| Control | 0..1 |
| Type | CodeableConcept |
| 2348. InvestigationalMedicinalProduct.UndesirableEffects | |
| Definition | 9.9.2.4 |
| Short | 9.9.2.4 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 2350. InvestigationalMedicinalProduct.UndesirableEffects.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 2352. InvestigationalMedicinalProduct.UndesirableEffects.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.UndesirableEffects.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 2354. InvestigationalMedicinalProduct.UndesirableEffects.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 2356. InvestigationalMedicinalProduct.UndesirableEffects.UndesirableEffectText | |
| Definition | The text of the undesirable effect shall be given. (9.9.2.4.2) |
| Short | The text of the undesirable effect shall be given. (9.9.2.4.2) |
| Control | 1..1 |
| Type | string |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| 2358. InvestigationalMedicinalProduct.UndesirableEffects.UndesirableEffectAsSymptom-Condition-Effect | |
| Definition | The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3) |
| Short | The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3) |
| Control | 0..1 |
| Type | CodeableConcept |
| 2360. InvestigationalMedicinalProduct.UndesirableEffects.Symptom-Condition-EffectClassification | |
| Definition | The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4) |
| Short | The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4) |
| Control | 0..1 |
| Type | CodeableConcept |
| 2362. InvestigationalMedicinalProduct.UndesirableEffects.FrequencyOfOccurrence | |
| Definition | The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5) |
| Short | The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 2364. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics | |
| Definition | 9.9.2.5 |
| Short | 9.9.2.5 |
| Control | 0..* |
| Type | BackboneElement |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 2366. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 2368. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics.extension. The slices are unordered and Open, and can be differentiated using the following discriminators: , and can be differentiated using the following discriminators: |
| 2370. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics.modifierExtension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. |
| Short | Extensions that cannot be ignored even if unrecognized |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them |
| Summary | true |
| Requirements | Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. |
| Alternate Names | extensions, user content, modifiers |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 2372. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics.Age | |
| Definition | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) |
| Short | The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2) |
| Control | 0..1 |
| Type | CodeableConcept |
| 2374. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics.AgeRangeLow | |
| Definition | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) |
| Short | The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3) |
| Control | 0..1 |
| Type | Quantity |
| 2376. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics.AgeRangeHigh | |
| Definition | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) |
| Short | The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4) |
| Control | 0..1 |
| Type | Quantity |
| 2378. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics.Gender | |
| Definition | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) |
| Short | The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5) |
| Control | 0..1 |
| Type | CodeableConcept |
| 2380. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics.Race | |
| Definition | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) |
| Short | The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6) |
| Control | 0..1 |
| Type | CodeableConcept |
| 2382. InvestigationalMedicinalProduct.UndesirableEffects.PopulationSpecifics.PhysiologicalCondition | |
| Definition | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) |
| Short | Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7) |
| Control | 0..1 |
| Type | CodeableConcept |